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, […]
The cat is out of the bag and so are CBD and other cannabis products. You can find CBD in almost anything (creams, ointments, lotions, foods, supplements) and almost everywhere, including gas stations, 7-Elevens, supermarkets, flea markets, and fairs, etc. I am certain that Amazon drones will be dropping it off at your front door […]
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 […]
On June 11, 2019, the FDA held a CDRH webinar on the Q-Submission Program for Medical Device Submissions. The webinar was based on the recent May 7, 2019 Final Guidance document titled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” This guidance document supersedes “Requests for Feedback on Medical Device Submissions: […]
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 […]
