The FDA issued its final guidance on Field Alert Reports (FARs) today (here). This guidance finalizes the draft guidance of the same title issued on July 19, 2018. FARs have been the subject of much misunderstanding and interpretation regarding when, what, how, and where reports should be sent. I can’t tell you how many times […]
The FDA announced the Generic Animal Drug User Fee Rates for FY 2022 in today’s Federal Register here. This will be a first in an avalanche of announcements of new User Fee rates for the coming FY. The rates for Generic Animal Drugs for FY 2022 are provided in the table below: Fee Category […]
With the news that domestic inspections are back on track the question comes with what is the backlog and how long will it take to slug through the outstanding inspections work? Question number 2 is then what do we anticipate seeing from these new domestic inspections? With it being over a year+ (March 2020) since […]
If you have been in the generic industry for, as they say, a minute, you know that one of the major and years old problem generic applicants have faced is being able to obtain samples of the reference listed drug (RLD) product to use in required bioequivalence (BE) testing to support approval of an abbreviated […]
As of today, July 19, 2021, FDA has posted its approvals up to and including July 15th, and the scorecard thru the top of the 4th inning is reported at 27 full approval actions and 2 tentative approval actions. If the current rate of approval actions holds for the month, we should see total approval […]
We have heard a lot about the use of real world evidence (RWE) and real world data (RWD) lately in the context of potential approval of new uses of approved drugs. Well, on July 16, 2021, FDA “approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of […]
Dr. Janet Woodcock, the Acting FDA commissioner, is a long-time career executive having begun her tenure in 1986. Full disclosure, I worked with or for her when I was at the Office of Generic Drugs from 1985 through December 1995 in various capacities. She has been serving as Acting Commissioner since her appointment for over […]
The trade press has reported that at least three of the major four user fee acts (UFAs) are close to wrapping up negotiations for the new five-year reauthorization period beginning in October 2022, but we have not heard where GDUFA III is in the process. As noted in a previous post (here), we wondered why […]
Happy July 9th! Hope you had a great Fourth of July weekend, but now it’s time to get back to business. The OGD seems to have squeaked by its lowest month totals of approval actions this FY (for May) as it appears to have recorded sixty total-approval actions for June, at least through the July […]
“Surprise” seems to be the best word to describe the updated May statistics report regarding the issuance of refuse-to-receive actions (RTR), which was reported as eleven (eight for standard ANDAs and three for priority ANDA submissions). It has not been since June 2018 that so many RTRs were issued. There is no telling whether this […]
