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 […]
Yesterday, FDA announced the eligibility of ANDAs submitted for drug products indicated for the emergency treatment of known or suspected opioid overdose, to be granted priority review status (either shorter goal dates, or expedited review without formal reduction of the goal date) under the public health emergency option stated in MAPP 5240.3 (priority criterion number […]
We reported here that June may be a gloomy month for approval actions. A few days ahead of the release of the official OGD numbers, it looks like we were on target. As reported through this morning on FDA All Approvals List (here), OGD had issued 44 full approval actions and 17 tentative approval for […]
The Report issued each year by the Office of Compliance (OC) is a treasure trove of facts and figures espousing the accomplishments of the OC. The 32 page document (which can be found here) provides a detailed account of OC actions in the enforcement arena, guidance area, consumer awareness and education area, actions relative to […]
This time of year, in southern California, the marine layer (low fog and clouds) hangs over the first few miles of the coast. We call it June gloom. Everyone either goes inland to see the sun or just waits it out until the Fourth of July weekend when the weather usually turns to the glorious, […]
In two separate Federal Register (FR) notices today, the FDA announced a public hearing (here) to be held on September 17, 2019. The notice states: This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, […]
Having lived through the days at FDA when sponsors called the FDA asking if anyone had submitted a Paragraph IV patent challenge for a specific drug and was thus potentially eligible for 180-day exclusivity as being a first-to-file applicant, the move to the PIV database was a godsend as it took the pressure off us […]
It seems that FDA is updating its First Generic Approvals list a bit more frequently. As reported on May 17 (here) the number of First generic Approvals was 43 (please read that post for the definition of first generic approval and other interesting information about the report). Yesterday the FDA updated its list through May […]
The Office of Generic Drugs released its first set of metrics this morning for May which shows (as previously reported here), 83 full approval actions and 12 tentative approval actions (1 more in each category than estimated in the post cited above), for a total of 95 approval actions. This is the first time this […]
In our post from June 10, 2019 (here), we commented on an apparent revision in the number of approved ANDAs from the month of April (a change from 98 to 93). While scratching our heads about the apparent discrepancy, the FDA’s Kristofer Baumgartner, M.A., Director, Division of Public Education and Outreach, came to the rescue […]
