FDA’s New ANDA Submissions Guidance: Key Points
Sep27

FDA’s New ANDA Submissions Guidance: Key Points

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to help industry increase the quality and suitability of electronic common technical document (eCTD) submissions by identifying the information that an applicant should include to ensure that a complete, high-quality application is submitted to FDA.

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Updated EU eCTD Validation Criteria
Aug28

Updated EU eCTD Validation Criteria

The European Medicines Agency (EMA) updated version 7.1 EU eCTD Validation Criteria will come into force September 1, 2018.  The changes in the validation criteria relate mainly to change requests received from regulatory bodies and taking experiences with version 6.1 into account. 

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New 3rd Acknowledgement for ESG Users
Aug21

New 3rd Acknowledgement for ESG Users

Beginning September 4, 2018, a new third Acknowledgement for ESG users will be sent for all submissions sent to the CBER in eCTD format.

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NeeS: A Thing of the Past
Apr10

NeeS: A Thing of the Past

With 2018 well underway, if you’re still not submitting in electronic Common Technical Document (eCTD) format in Europe, now is the time to transition. Non-eCTD electronic Submission or “NeeS” have been accepted for many years. However, they are becoming less common for National Procedures. Furthermore, at the end of this year, NeeS will be a thing of the past.  On 10 March 2017, the European Heads of Medicines Agenices (HMA) announced that eCTD will be mandatory for all regulatory activities in National Procedures as of January 1, 2019.

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Reminder: Drug Sample Compliance Reports Are Due
Mar20

Reminder: Drug Sample Compliance Reports Are Due

The Affordable Care Act requires pharmaceutical companies that dispense drug samples to physicians and health care professionals to report annually on the details of the samples dispensed. The government mandated this electronic reporting of all drug samples annually, by April 1 each year. The intent of the legislation is to help FDA monitor prescription drug distribution activity and prevent abuse.

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