The United States Food and Drug Administration and the Indian Government join forces in “Operation Broadsword”. No, it’s not a trailer for an action thriller, it’s a serious collaboration between two governmental entities to limit the import and sale of illicit drugs to consumers, detailed in FDA’s news release on February 18, 2020 (here). The […]
February 14, 2020 could be called a red letter day in the world of Rx-to-OTC switch. After a long period of drought, FDA announced that they have approved the Rx-to-OTC switch of three prescription drugs. Please see the announcement here. The three drugs are: Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary […]
The official OGD stats are out for approval and tentative approval actions, as well as complete response letters issued and receipts of original ANDAs. In January 2020, OGD issued 49 full approval actions, the lowest by far for FY 2020. Of those 49, only one was cited as a first-time approval (I think this might […]
In earlier blogs, we have written about specific technical items related to identity testing. However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]
The FDA’s Office of Pharmaceutical Quality (OPQ) is the group within the FDA that defines the quality requirements for all human drugs under its umbrella (filed as NDAs, ANDAs, BLAs, 351(k)/Biosimilars, and OTC products). The group issued its 2019 Annual Report just this month (read the full report here) that includes a look back […]
February 3, 2020 was the last day to comment on the Food and Drug Administration’s (FDA) notice in the Federal Register on the Novel Excipient Review Program Proposal; Request for Information and Comments (here), which we reported on in a previous blog post (here). In this notice, the FDA had proposed a pilot program related […]
As of February 4, 2020, there have been 49 full approval actions and 13 tentative approval actions posted for January 2020. As always noted, these number come from the available data on FDA’s All Approvals site (here) and FDA’s Recent New and Generic Drug Approvals list which is updated daily (here). The official numbers will […]
If you are, or plan to be a sponsor of a Generic ANDA, do not let this slip by you. The FDA on January 30, 2020 revised its Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements to make changes to the prioritization scheme for the review […]
Many years ago, I wrote an article on the influx of Pharmacy Benefits Managers (PBMs) on the cost of prescription drugs (this was before much was really known about how they operated). In that article, I opined that I thought that they would be a great benefit to organizations that were not big enough to […]
The FDA has provided a list of all products approved under the Competitive Generic Therapy (CGT) designation program under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This exclusivity is awarded for products with limited generic competition and provides for a potential 180-day exclusivity marketing period. On its current list (here), […]
