Many thanks to the FDA for publishing several important new and revised guidances and a proposed rule related to the Biopharmaceutical industry this week. These include a finalized version of the “Deemed to be a License” Guidance for industry (here) with several important revisions and additions relative to the previously published draft,
Well, since the first draft guidance on the “deemed approved” transition provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), we have been waiting to learn more about the specific process and for answers to a number of questions. FDA just issued a second revision of the question and answers document (here).
The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here). The notice states that:
Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.
On Thursday (September 20th), the FDA held a meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss the Agency’s plans for implementation of the Knowledge‑aided Assessment and Structured Application program (KASA). The FDA presented to the Advisory Committee two primary goals of the KASA program. On the one hand, it is intended to make the review of the CMC section of NDAs,