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In September, the FDA issued its Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017.
There are many proposed improvements related to the FDA review procedures, including a mandate of the eCTD. This mandate will start 24-months after publication of the corresponding final guidance for marketing applications and 36-months after publication of the final guidance for commercial INDs and amendments.
The final guidance will be released no later than 12 months from the close of a public consultation period on the draft guidance. The corresponding draft guidance will be issued by December 31, 2012 at the very latest. The initial guidance will reference eCTD version 3.2.2; however, the final guidance might refer to a different standard, namely RPS, if the FDA determines the new standard is more efficient and effective. The FDA also mentions that they “shall also accept submissions using the previous version for no less than twenty-four (24) months.”
Although many of the goals for priority and standard NDA and BLA review (including Class 1 and Class 2 resubmissions, efficacy supplements, and manufacturing supplements) remain the same as under PDUFA IV, the proposed PDUFA V agreement establishes a new review model that will apply to all New Molecular Entity (“NME”) NDAs and original BLAs received from October 1, 2012 through September 30, 2017, including applications that are resubmitted following a refuse-to-file action.
The new program includes a pre-submission meeting, a mid-cycle communication, and a late-cycle meeting at which the FDA review team and the applicant will discuss the status of the review of the application. At the pre-submission meeting, the FDA and the applicant will agree on the content of a complete application for the proposed indication(s), and the applicant may also reach agreement on submission of a limited number of application components.
Another important change is the treatment of “major amendments” to pending applications.
Under PDUFA IV (and FDA’s regulations at 21 C.F.R. § 314.60), “[a] major amendment to an original application, efficacy supplement, or resubmission of any of these applications, submitted within three months of a goal date, may extend the goal date by three months. A major amendment to a manufacturing supplement submitted within two months of the goal date extends the goal date by two months” (emphasis added). Under the proposed PDUFA V agreement, however, “[a] major amendment to an original application, efficacy supplement, or resubmission of any of these applications, submitted at any time during the review cycle, may extend the goal date by three months”, and “[a] major amendment to a manufacturing supplement submitted at any time during the review cycle may extend the goal date by two months.”
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GlobalSubmit recently held an educational webinar entitled Intro to eCTD.
Under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Given this recent news, GlobalSubmit offered this free webinar to provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. If you were able to join us, we hope that you now feel better prepared to make the switch from paper to eCTD.
We received several great questions during the webinar, but unfortunately did not have time to address all of them. Please find these questions and answers below.
Q: If a company is submitting its first eCTD, is it necessary that they first get some dummy file validated or checked by the USFDA and then submit the real dossier?
A: No. That said, if you are creating the submission by hand, then it would be a good idea to submit some dummy files first.
Q: What would you consider to be the best publishing and validation software?
A: We certainly feel that we have the best offering for publishing, validation, and review. Our VALIDATE and REVIEW products are the very tools used by the FDA, and so the need for quality is quite clear. PUBLISH has been built to be simple, intuitive, and easy to use, and is built on our solid foundation of VALIDATE and REVIEW
Q: Where can I get a copy of the ICH guidelines?
A: The current ICH eCTD specification, V3.2.2, can be found on the ICH website.
Q: How should SAE safety reports be submitted in eCTD and to which module are they submitted?A: You should submit all serious adverse events through the FDA electronic submission gateway within the requisite time, preferably in ICSR format.
Q: What is the eCTD format for submitting Annual Report? Is there any guidance?A: The FDA provides a submission type for submitting Annual Reports and an annual report is formatted in eCTD like all other submission types. Q: When will the FDA no longer accept any submission in paper?A: The FDA currently plans to mandate eCTD submissions in 2015. Q: In MODULE, 5 it is shown as ISS ISE, what exactly does it mean?A: ISS and ISE stand for Integrated Summary of Safety and Integrated Summary of Efficacy, respectively. They would generally follow the same format as a clinical study and would be submitted in. Q: What is the file type we use for checksum? Q: Do we have any standard template for NDA and IND submissions to FDA?A: The FDA has Application Types for NDAs and INDs, with guidelines for each type. Q: Can we submit both non clinical (module 4) and clinical trials (module 5) at once? If so, in which application type can we submit? Q: In the study tagging file specification we go through new/append/replace/delete. In what circumstances is it shown and how it is used? It is mentioned as same name as the study, I just want to know whether it is study id or study title? Q: What is the difference between the publisher and author of application? Q: When lifecycling Annual Reports section 1.13, should these be done as NEW every reporting period or should a new reporting period REPLACE the previous year’s reporting period? kerala net cafe kerala nude beach kerala lss malayalam question paper kerala nri wife kerala husband wife fuck kerala naked aunties Q: How do you select the right electronic publishing software for eCTD? Q: Some word files are also used in the submission, how we will ensure its integrity after submission?A: The integrity of the data can be checked at any later time by recomputing the checksum and comparing it with the stored one checksum in the submission. If the checksums match, the data is not altered. Thank you again to all of those who participated in the webinar. For your reference, the webinar slides are now available for download here. We look forward to seeing you at future events.
A: Checksums are generally stored as an attribute in the backbone and regional XML files, with the exception of the checksum for the backbone itself, which will be a text file in the root directory of the submission at the same level as the backbone XML file.MD5 is the checksum attribute that is used.
A: Yes, both clinical and non-clinical data can be submitted in the same sequence. The application type would be unrelated to this, and instead would be based on what type of application you intend to submit (e.g. NDA, ANDA, IND, etc.). The Submission Type would also depend on what stage of the application you are in, and what you’re submitting for (i.e. Original Application if you are on your initial sequence, Amendment if you are adding data to an existing sequence, or a Supplement if you are adding additional parameters to your application.
A: The study Id is the key identifier of the study tagging file. The operation (i.e. new, append, replace,and delete) will be located in the index.xml not the study tagging file.
A: An author is a person who is actually writing the documents themselves, compiling the document in Word or a similar tool. A publisher is a person who takes these finished documents and places them correctly in the structure of the eCTD and generates the XML and associated required files.
A: No. Annual Reports would be something you would want to persist. The best way to think of this is that when you are replacing a file, you are saying that the information and content of that document are no longer relevant and you are submitting a replacement for that data. Annual Reports represent cyclically collected data and would be something you would want to retain throughout the progression of your application.
A: We believe you should select publish software that eases your process, allows for greater productivity, and produces quality output.
As you may already know, under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Are you prepared?
Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. Your application must be technically sound and structured correctly. Most importantly, it has to be ready for review by the agency upon submission.
GlobalSubmit Inc., a leading developer of eCTD review and validation software for FDA use, wants you to be prepared for the trials and tribulations that occur while creating NDAs, INDs and related amendments.
That’s why GlobalSubmit is offering a free educational webinar Intro to eCTD on Wednesday, February 29th at 12:00pm EST.
During this discussion, we will provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. By the end of this session, you should feel better prepared to make the switch from paper to eCTD.
Top 3 Learning Objectives:
1. Understand eCTD terminology and rules
2. Realize the challenges of eCTD and solutions to address those challenges
3. Learn how to assemble a basic eCTD application
For more information and to register: GlobalSubmit Events
Regulatory Submissions Made Easy, Part III
posted by GuestPost @ 12:41 PM
Wednesday, February 15, 2012
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Today’s entry was provided by Matthew J. Neal, Director of Knowledge Management & Innovation in Global Regulatory Affairs & Safety at Amgen, Inc. in Thousand Oaks, CA. He led the Regulatory Operations group there for seven years and managed submissions for GSK in Philadelphia, PA for 7 years before that.Hey Everyone. It has been a few months since my last entry. I trust your holidays were enjoyable. Hopefully you didn’t think about work too much. That’s what this final chapter is going to focus on, actually – not thinking about work.
In the previous installments, I talked to you about the tools and teams to help you make regulatory submissions easy. But since I’m going to assume that since I left you alone there for a few months that you’ve already got that finished and we can move on to the most important part – becoming the laziest team in your organization. As you may recall, in Part One, I said “Efficiency born out of laziness is one of the most powerful drivers of innovation and automation.” The only way to get to the point where you are not thinking about work is when you know your team is a well-oiled machine that will not break down. You know you have the right tools, people, and process.
The biggest stress and source of difficulty, of course, is waiting for final documents. While this is a concern for every Regulatory Operations team, in the grand scheme, you have no real control over this common phenomenon. So, the best you can do is be ready to react and have confidence in your team to work quickly and efficiently when the documents finally come through. The good news is, while you’re waiting – you can relax (more not working) knowing how well your Operations machine works.
I would like to close this series with a story that will give you hope (I hope). When I first joined the wacky world of Regulatory Operations a long, long, time ago, a Marketing Application event was monumental and scary. The sounds coming from the assembly area were loud and striking. Hole punchers, printers, and page number stampers echoed through the building for weeks leading up to the submission date. Multi-colored binders flew up in the air, paper cuts were rampant, and the little rubber fingers for checking pages stayed on in all situations. As the day really approached, the sound of boxes being assembled and tape guns furiously sealing up a mountain of cardboard replaced the earlier mayhem. Tape guns was a great sound to hear, until someone came running in with a late breaking change…then the ripping sound made everyone sad. Soon, a U-Haul was loaded with boxes and team photos were taken and the waiting began.
Several years later, as the lead publisher and I walked the fake DVD’s over to the Lead Regulatory Rep for a photo op (the submission was sent through the Electronic Regulatory Submissions Gateway, so there was nothing to photograph or hold) and there was calm. There was no noise. There was no mayhem. There was no U-Haul. There was no paper. We reminisced about the past and how much drama used to happen before electronic submissions. All that drama was now the press of a button. A 100% electronically QC’d, integrated package sent through the digital realm (almost) instantly. No trucks, no binders, no paper, no tape, no page stamper, no boxes. We didn’t miss it and you will not miss it either. I believe the remark was, “Oh, that’s it, huh?”. Yep, that’s it. The publishers were able to be lazy, relaxed, finished – and going home at 5:00. While we can’t always achieve the 5:00 thing – we should always aim for it. Life’s too short. Thanks for reading.
An innovative approach to fight viral pathogens has been discovered by researchers at the Massachusetts Institute of Technology (MIT). The new drug DRACO, an acronym for double-stranded RNA activated caspase oligomerizers, has the potential to fight many known viruses, including the common cold, flu, stomach viruses, polio, and many more. While the drug is still several years away from clinical trials, DRACO has seen early success in the laboratory. DRACO has demonstrated that it is nontoxic in 11 mammalian cell types, effective against 15 different viruses, and eradicates H1N1 in infected mice.
This groundbreaking treatment employs a novel approach to viral infection. While current therapies typically target a specific virus and often have undesirable side effects, DRACO covers a broad spectrum of viruses by targeting genetic material found only in infected cells. When a cell is infected, a virus reprograms the cell to make copies of the virus. While manufacturing new viruses, the cell creates double-stranded RNA (dsRNA) which is not normally found in healthy human and animal cells. DRACO is designed to enter cells that contain dsRNA and then deliver a message for the cell to self-destruct, a process called apoptosis. In doing so, cells that are infected are quickly destroyed and additional copies of the viruses cannot be made. Because DRACO is specifically designed to only enter cells with dsRNA, healthy cells are left alone.
Even though DRACO is still in the laboratory, the ingenuity of this novel approach to drug discovery is refreshing. As traditional drug discovery continues with its struggles, these types of groundbreaking ideas are critical to ensure new therapies are found in the future.
For more information, click here.
Mergers and Acquisitions, A Regulatory Operations Perspective – Part II
posted by GuestPost @ 7:49 AM
Wednesday, January 11, 2012
Today’s entry was provided by Rachel A. Wagner, LinkedIn Profile.
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MS Excel is a tool that I have found most reliable for developing the inventory listing. Excel can be used to inventory the documentation, export/import information to a database (in a tab delimited format), and then validate/verify the received inventory.
The spreadsheet will include such information as date of document/submission, submission number, document/submission type, description, and other data deemed valuable for the product history. Another suggestion is to keep an overall list of the products. This spreadsheet might include the product name and dosage, the type of submission (NDA, ANDA, IND, etc.), the status of the submission, the regulatory agency/division, etc.
Once the inventory is collected, inventoried, and ready for transfer, the next step is to find a good method for the interchange of the inventory. There are many good methods to choose from including eRooms, portable hard drives, CD/DVD, FTP/SFTP sites, and of course the legacy paper being shipped via courier.
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netprof Once the inventory of product documentation is received and verified electronic submissions must be quickly integrated into the corporation’s eCTD publishing tool. This can be challenging. I suggest utilizing the expertise of the vendor. Vendors know their software much better than most RegOps staff and can be quite useful in integrating the submissions quickly into the publishing system.Hard copy documentation must be assessed for future use. A decision should be made to scan the documents or merely validate the inventory and store the documents. If the decision is made to scan the documents, do so in black and white to keep file size to a minimum (gray scale and color scanning usually results in a larger file size).
It is important, during the process of in/out-licensing, to include Information Technology staff in the process of collecting and receiving documents and data. Information Technology staff can be quite useful by ensuring the clean transfer and permanent storage of documents for out-licensing and smooth acceptance and storage of documents during in-licensing. Information Technology staff will ensure there is sufficient drive space and networks are not bogged down, important logistical requirements for the acceptance of a large inventory of documentation and data. Information Technology will also ensure that the security settings for folders are properly set.
Strategies for ensuring all of the above is done with little interference starts at the top. Executive management may consider creating a strategic plan for in/out-licensing and mergers and acquisitions. This strategic plan should include the technical aspects of such an undertaking. Such topics as systems to be used, network and security, and staff involvement (including when to involve staff) are important strategies to ensure success.
Additionally, it is recommended that RegOps and Information Technology collaborate to create a strategic plan for the necessary tasks they will have to perform during these activities. A full understanding of the corporate systems and processes is vital to the success of the integration and divesting of products. This information is important to ensuring the newly acquired information is quickly integrated into the corporate system and that information being sent during a divestiture is quickly gathered.
To ensure success a few high level recommendations are suggested:
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Ensure the current practices work whether they be methods for storage or publishing practices.
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Involve RegOps and IT early in the process to ensure quick and accurate collection of inventory.
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Be flexible and scalable not just in the technology but also in the utilization of staff and outside assistance.
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Use contractors, temps, and vendors when necessary.
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Understand and leverage the expertise and knowledge of staff, including newly acquired staff.
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Processes, tools, and management may change, be prepared to manage the transitions.
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Understand that there will be stressful times during the process. Recognize the signs of stress and handle them quickly.
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Remember that people are a corporation’s most valuable resource, keep them informed and let them know they are important to the success of the current undertaking.
Mergers and Acquisitions, A Regulatory Operations Perspective – Part I
posted by GuestPost @ 3:30 PM
Monday, December 19, 2011
Today’s entry was provided by Rachel A. Wagner – LinkedIn Profile
I had the great privilege of speaking at the DIA eCTD conference this past November. The subject of my talk was on the out-licensing and in-licensing of products. Many of you may have had to undertake these tasks in the recent past as this has become a frequent occurrence in our industry. This is the first entry of a two part post where I will share my experiences during the past year including the issues and lessons learned.
The purpose of out-licensing is to raise money for the corporation, or to divest a developed technology. During the out-licensing process it is necessary for the RegOps group to organize and transfer the information and documentation to the new company. This may include the submissions, labeling, correspondence, and other documentation for the product. Additionally a chronology of the product documents, whether that be hard copy, electronic, or both should be included as an “inventory” check.
In-licensing is accomplished to add new products to the corporate pipeline, and procure resources needed for final-stage development, clinical trials, manufacturing, and distribution of products. It should be noted that with any in-licensing there will be a large amount of incoming inventory (documentation) and there is normally an urgency to integrate and streamline the information being received. The documents must be added to the corporate network folders, the EDMS, the publishing system, or other storage methodologies. This must be done quickly and accurately.
The merger/acquisition of companies brings the same type of product on-boarding to a corporation along with the integration of staff and possibly the integration of divergent systems.
There are many tools and methods to make these challenges and opportunities less difficult. These tools will be used to transfer information, inventory documents, and validate the received inventory.
Transfer of Documents:
Transfer of documentation should be done in a logical structure. To this end it is important to create a folder structure that is logical to follow. One suggestion is to create a folder structure that includes such a format as:
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Product
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Country-
Submission Type
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Submissions
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Correspondence
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Labeling
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Data
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If the corporation does not already have a logical folder structure for storing the inventory of documents that are vital to a product portfolio, I suggest starting that procedure prior to in/out-licensing. Waiting until the critical moment to do this is time consuming and will delay the timeline for completion of the project.
In part two of this topic I will discuss best practices, strategies, and the tools used during my experience.
During the opening session of the recent DIA Electronic Submissions Conference in San Diego, Gary Gensinger, Deputy Director, Office of Business Informatics at CDER spoke about the not-too-distant future at the FDA when electronic submissions will become mandatory. Under the draft PDFUA V bill, electronic submissions will be mandated and Gary provided us a timeline for the implementation under the proposed mandate.
In December 2012, the FDA will release draft guidance for this new era, which, among other things, will require electronic submission. The draft guidance will be open to comment for a period of 6 months followed by the release of the final version. It will then be implemented 2 years after the final version, bringing us to mandated electronic submissions in Q2 2015.
There is another important take-away from this presentation. In the future, the FDA will use this same pattern for implementation of new requirements and guidance. We can expect when the FDA alters its requirements the following timeline will be used:
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Draft guidance will release for public comment
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Six-month comment period
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Revision and release of the final version
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Implementation of the changes 2 years later
With this pattern in place, the process of iterative improvement of FDA standards should be much more consistent going forward. For sponsors, this means greatly improved predictability which allows for greatly improved preparedness
As mentioned in an earlier blog from Rahul Mistry, the FDA currently accepts PDF 1.4 and will soon except PDF 1.7. Does this mean that you need to upgrade all of your PDF’s from 1.4 to 1.7?
There is a very simple answer – No.
The specifications for PDF are backward inclusive. This means that the PDF 1.7 specification includes all of the functionality previously documented in the Adobe PDF Specifications for versions 1.0 through 1.6. Below is a list of all of the new features that Adobe has implemented in the PDF specification. If you are not using any of the new features below, a PDF 1.7 file and PDF 1.1 file are identical, with the exception of the version number which is embedded in the metadata.
| Acrobat Reader Version | PDF Version | New Features |
|---|---|---|
| Carousel | 1 | Initial Version |
| 2 | 1.1 | Passwords, encryption (MD5, RC4 40bit), device-independent color, threads and links |
| 3 | 1.2 | Interactive page elements (radio buttons, checkboxes); interactive, fill-in forms (AcroForm); Forms Data Format (FDF) for interactive form data that can be imported, exported, transmitted and received from the Web; mouse events; external movie reproduction; external or embedded sound reproduction; zlib/deflate compression of text or binary data; Unicode; advanced color features and image proxying |
| 4 | 1.3 | Digital signatures; ICC and DeviceN color spaces; JavaScript actions; embedded file streams of any type (e.g. used for attachments); new annotation types; new features of the Adobe PostScript Language Level 3 imaging model; masked images; alternate representations for images; smooth shading; enhanced page numbering; Web capture — a facility for capturing information from World Wide Web and converting it to PDF; representation of logical structure independently of graphical structure; additional support for CIDFonts; data structures for mapping strings and numbers to PDF objects; information for prepress production workflows support; new functions for several function object types that represent parameterized classes of functions |
| 5 | 1.4 | JBIG2; transparency; RC4 encryption key lengths greater than 40?bits (40–128 bits); enhancements to interactive forms and Forms Data Format (FDF), XML form submissions, embedded FDF files, Unicode specification of field export values, remote collaboration and digital signatures in FDF files; accessibility to disabled users; metadata streams using XML — Extensible Metadata Platform (XMP); tagged PDF; inclusion of printer’s marks; display and preview of production-related page boundaries; new predefined CMaps; alternate presentations; importing content from one PDF document into another; Embedded Files entry in the PDF document’s name dictionary — a standard location for the embedded data; OCR text layer |
| 6 | 1.5 | JPEG 2000; enhanced support for embedding and playback of multimedia; object streams; cross reference streams; XML Forms Data Format (XFDF) for interactive form submission (replaced the XML format in PDF 1.4); support for forms, rich text elements and attributes based on Adobe’s XML Forms Architecture (XFA) 2.02; public-key security handlers using PKCS#7 (introduced in PDF 1.3 but not documented in the Reference until 1.5), public-key encryption, permissions — usage rights (UR) signatures (does not require document encryption), PKCS#7 with SHA-1, RSA up to 4096-bits; security handler can use its own encryption and decryption algorithms; document sections selectively viewed or hidden by authors or readers — for items such as CAD drawings, layered artwork, maps, and multi-language documents; Alternate Presentations — the only type is slideshow — invoked by means of JavaScript actions (Adobe Reader supports only SVG 1.0); support for MSWindows 98 dropped. To view and print newer version PDFs, such as those at the IRS, with older versions of Reader requires downloading in Google Docs “Quick View” simplified PDF format. |
| 7 | 1.6 | 3D artwork, e.g. support for Universal 3D file format; OpenType font embedding; support for XFA 2.2 rich text elements and attributes; AES encryption; PKCS#7 with SHA256, DSA up to 4096-bits; NChannel color spaces; additional support for embedded file attachments, including cross-document linking to and from embedded files; enhancements and clarifications to digital signatures related to usage rights and modification detection and prevention signatures |
| 8 | 1.7 (ISO 32000-1:2008) | Increased presentation of 3D artwork; XFA 2.4 rich text elements and attributes; multiple file attachments (portable collections); document requirements for a PDF consumer application; new string types: PDFDocEncoded string, ASCII string, byte string; PKCS#7 with SHA384, SHA512 and RIPEMD160 |
| 9 | 1.7 Extension Level 3 | 256-bit AES encryption; incorporation of XFA Datasets into a file conforming PDF/A-2; improved attachment of Flash applications, video (including Flash video with H.264), audio, and other multimedia, two-way scripting bridge between Flash and conforming applications; XFA 2.5 and 2.6 rich text conventions |
| 9.1 | 1.7 Extension Level 5 | XFA 3.0 |
| X (10) | 1.7 Extension Level 5 | XFA 3.0 |
FDA and PDF Specifications: An Evolving Matter
posted by Rahul Mistry @ 12:21 PM
Tuesday, November 22, 2011
I am often asked, “Which version of Adobe Acrobat is the FDA using?”. This question is usually followed by, “Which version of PDF can I submit to the FDA?”.
The answer to the first question is that the FDA currently uses Adobe Acrobat 8 with plans of upgrading to the new version, Adobe Acrobat X, in the near future.
The answer to the second question is a bit more complicated. Since the FDA uses Adobe Acrobat 8, they have the ability to view PDF versions 1.0 to 1.7. That being said, they do not support all of these versions.
As many of you know, the FDA issues eCTD Guidance and Specifications to clarify implementation of regulations. In the currently posted specification concerning PDFs dated June 4, 2008, the official PDF version is 1.4, which is supported in Adobe Acrobat 5 and later.
As new versions of the PDF specifications are released, they are evaluated for future acceptance. Therefore, the answer to the question “Which version of PDF can I submit?” changes as the PDF standards evolve. At the DIA Electronic Submissions Conference in San Diego held November 15th-17th, the FDA announced that it will now accept any PDF version between 1.4 and 1.7. While these are the acceptable versions stated by the FDA, earlier versions of PDF’s can still be submitted. See next week’s post.
I also learned that ICH members will also accept PDF versions 1.4 through 1.7 soon. Corresponding with this announcement, the FDA will update their PDF Specifications for the first time in over three years. The updated specification is scheduled to be posed by year end.