Well, for the first time, our initial estimates of approval actions for a month was higher than the reported official figures, but are they really? Don’t know exactly how that happened because our estimates are usually below the totals. Anyway, the official figures posted today (here) were eight-two full approvals and seventeen tentative approvals. However, […]
In my own humble opinion, Scott Gottlieb’s resignation will come as a blow to both the industry and the public health of our nation. Dr. Gottlieb will stay in his position for about a month. There is no speculation as to whom his replacement will be, and, while some of the news outlets cite his […]
So far, for February 2019, it looks like OGD fully approved 83 ANDAs and tentatively approved 23 ANDAs. Of course, the final official numbers won’t be in for about another week or so, but it looks like another month in the 100’s (OGD total of 100 or greater approval actions was missed only one month […]
The FDA has revised and finalized a guidance document, originally issued in draft on March 26, 2018, entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act (here). After the posting of the draft guidance, the FDA says that it received approximately sixty […]
The Office of Generic Drugs issued its 2018 Annual Report, which contains the accomplishments of the generic drug program over the past calendar year. The report (here) provides data on approvals and tentative approvals, as well as other actions that OGD has taken over the year. Included in the report are links to various operational, […]
Today, the FDA issued a guidance titled Quality Considerations for Continuous Manufacturing (here). Talk about a controversial proposition! The generic industry has long held that implementation of continuous manufacturing might not be appropriate for their business. Why? I am not always clear on the answer to that question, but change is always difficult, especially when […]
Today, the FDA issued twenty-two new bioequivalence recommendations, some of which were for some fairly old products, including a couple of DESI drugs. There were no surprises in the newly issued listings; however, as we have gone on about previously, the FDA has also issued fifty-two – yes, fifty-two – revisions to previously issued guidances. […]
Much like all we do at tax time, we look for anything that might lower our taxes. We look for deductions, charitable gifts, donations, business expenses and do a lot of hope and praying. Well, FDA had a corollary situation when they were looking at how to count and where to place ANDAs in the […]
Today, the FDA issued a guidance document titled “Competitive Generic Therapies (CGT)” which describes the new statutory requirements under section 506H of the FDA Reauthorization Act of 2017 (FDARA). CGT was enacted to promote and incentivize the development, expedite the review (and thus approval) of certain previously approved drugs with little or no competition. In […]
Today, the FDA announced the appointment of Sally Choe, PhD to succeed Kathleen (Cook) Uhl, M.D. as Director of the Office of Generic Drugs (Cook’s last day at OGD will be March 2). Dr. Choe currently serves as Deputy Office Director, Office of Study Integrity and Surveillance within Office of Medical Products and Tobacco, Center […]
