New FDA Initiatives: Project Orbis and Real-Time Oncology Review
Oct30

New FDA Initiatives: Project Orbis and Real-Time Oncology Review

The U.S. Food and Drug Administration (FDA) recently announced two exciting and innovative initiatives from FDA’s Oncology Center of Excellence: Project Orbis and Real-Time Oncology Review (RTOR) Pilot Program. Project Orbis Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), will provide a framework for concurrent submission and review of oncology products between international partners. The...

Read More
Final Guidance Includes eCTD Implementation Date for Promotional Materials Submissions
Aug05

Final Guidance Includes eCTD Implementation Date for Promotional Materials Submissions

Final Guidance and Implementation Date The U.S. Food and Drug Administration (FDA) has released long-anticipated final guidance with the implementation date for all promotional materials submissions via electronic common technical document (eCTD) format. The guidance titled, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription...

Read More
DIA’s RSIDM 2019: Highlights from the ‘Ask the Regulators’ Sessions
Feb21

DIA’s RSIDM 2019: Highlights from the ‘Ask the Regulators’ Sessions

Synchrogenix was well represented at DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Forum held earlier this month. One of the reasons RSIDM is such a valuable meeting for Regulatory Operations professionals is because it is so well attended by U.S. FDA staff members who participate both as speakers and fellow attendees. We particularly look forward to the “Ask the Regulators” sessions, where FDA representatives answer questions directly from the attendees. Following are highlights from the ‘Ask the Regulators’ sessions.

Read More
FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format
Oct16

FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the structure and implementation rules for the submission of computer readable datasets. SEND is one of the required standards for data submission to the U.S. Food and Drug Administration (FDA) and specifies a way to collect and present nonclinical data in a consistent format. The overall package consists of several components, but the focus is on individual study endpoint data which are typically mapped to datasets in domains with several variables in each study dataset.

Read More
Reminder: Establishment Registration Renewals are Due by EOY
Oct02

Reminder: Establishment Registration Renewals are Due by EOY

FDA Establishment Registration renewals for 2019 must be submitted between October 1 and December 31. With certain exemptions, any establishment engaged in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution is required to register with FDA annually. Registration is required within five days of introducing a product into commercial distribution.

Read More