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 FDA announced the availability of two draft labeling guidance documents today. One, titled Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format (for standardizing the instructions for use section of labeling), and the other, titled Drug Abuse and Dependence Section of Labeling for Human […]
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 […]
Today, in the Federal Register (here), the FDA announced a portion of its continuing modernization plan relative to better assessing its summary of approval that FDA prepares for all new NDA and BLA approvals. The notice asked for public comment on “the Clinical Data Summary Report Pilot program as part of the Agency’s continuous assessment […]
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 […]
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 […]
