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 […]
The pre-publication page of the Federal Register Notice posted today (here) a reopening of the comment period for the draft guidance Quality Considerations for Continuous Manufacturing which was originally released February 27, 2019. That guidance can be found here . While some (but not too many) firms have embraced the concept of continuous manufacturing, others […]
Late Friday afternoon, OGD updated its reported metrics for the month of April. Below are the highlights of the new data that was reported. You can review the entire report on the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) For the third month in a row, OGD refused-to-file (RTR) 6 […]
For the first time this fiscal year (FY), it looks like the OGD will have taken fewer than 100 total final and tentative “approval actions” in a month. While we await the official OGD figures (which should be reported sometime next week), so far, for May, as gleaned from the FDA “All Approvals” page (here), […]
In today’s prepublication of the Federal Register Notice entitled Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain (here), the Agency is opening a docket to receive comments on a requirement to blister package certain commonly prescribed opioid products in an effort to reduce the potential for over dispensing quantities […]
The list, published by the Office of Management and Budget, outlines a host of proposed and/or final rules the FDA “hopes” to publish, or at least consider, in 2019. Given the state of and the bent towards new or additional regulations in the current administration, this seems like an ambitious agenda for the Agency. The […]
A podcast/article written by LCDR Rinku Patel, Pharm.D., Patent & Exclusivity Team, Office of Generic Drugs Policy, provides a description of the Competitive Generic Therapies program (which we have described previously here and here). Since we have covered the program in detail and there is an FDA draft Guidance available (here), we will not go […]
In an interesting twist, a firm petitioned the FDA/DEA to request that a synthetic version of Cannabidiol (CBD) oil be placed in Schedule V of the Controlled Substances Act in order for the firm to submit an ANDA for a generic version of Epidiolex (a treatment for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome) […]
