On July 9, 2019, FDA finalized the Guidance for Industry titled, Risk Evaluation and Mitigation Strategies: Modifications and Revisions. The current Guidance updates the previous Guidance with the same name that was issued on April 7, 2015. The update is more of a finalization; the portion of the draft that sets forth the submission procedures for REMS revisions and modifications.
The annual meeting of AAM, Access 2019, is being held in the Hyatt Regency, New Orleans from February 4-6, 2019. The agenda of February 4th involved several sessions to be attended only by the members, including that of Science & Regulatory and Policy Working Group, and the Board Meeting. The Science & Regulatory Team discussed about the future of GDUFA and BSUFA,
The Fourth Annual Global Regulatory Affairs CMC Conference was held in Philadelphia on October 29‑30, 2018. The conference focused on successful developmental and post-market CMC operations and product lifecycle management tactics, based on better understanding of U.S. and global regulatory requirements for small molecules and biologics.
Talking of life -cycle management, the current draft of ICH Q12 loomed large as the deadline for comment by most regulatory bodies of the world is in December 2018.
The DIA Complex Drug-Device Combination Workshop was held at Sheraton Silver Spring on October 9‑10, 2018. The second day’s discussion was dominated by issues related to transdermal systems and intrauterine devices. The presenters on the second day were mostly from the FDA, with a few from academia and CROs. The FDA presenters focused on quality expectations for devices,
The DIA Complex Drug-Device Combination Workshop is being held at the Sheraton Silver Spring during October 9‑10, 2018. The first day of the conference dealt with the regulatory aspects of the generic submissions for these kinds of products, and discussions on clinical aspects related to complex generics, with a focus on inhalation products.
The meeting was well-attended,
The GRx+Biosims Conference held in Baltimore, MD from September 5-7, had a session on the GDUFA II Pre-ANDA Program for Complex Products on the last day, presented by FDA.
The presenter, Kris Andre, Associate Director of Regulatory Affairs, Office of Research and Standards, Office of Generic Drugs (OGD), discussed in detail the logistics and agency’s expectations related to the meetings for complex generics.
The GRx+Biosims Conference held at Baltimore, MD from September 5-7, had a panel discussion regarding Successfully Managing Priority Generic Submissions on September 6th. The panel members were representatives from the industry.
Discussions centered around the experience with priority submissions in the first year of GDUFA II. The consensus was that the submission of PFC (pre-submission facility correspondence) related to the priority submissions were labor intensive.
In August 2018, the ICH Q11 Implementation Working Group (IWG) published training material in the form of a PowerPoint presentation for better clarification of ICH Q11 Questions & Answers – Selection & Justification of Starting Materials. The presentation can be found here: Q11 IWG – slide deck training material (choose “read only” option to view) .