The proverbial title of a 1962 hit song by Petula Clark is something that piqued my curiosity today. And yes, I am that old (I was 13 when that song came out and I loved to play with my pet dinosaur). Anyway, I digress! The reason I bring up “Never on Sunday” is, because, as […]
In today’s global marketplace, industry is responsible for adhering to regulations in all markets that their products are in. Today’s pharmaceutical supply chain also likely contains partners that are across many geographic regions, and regulators expect conformity. In addition, regulators expect proactive compliance, and concerns about a retroactive “lack of assurance” of GMP are frequently […]
Well, the first quarter of approval actions for original ANDA and receipts are in the books. We reported late last week that OGD fully approved 78 ANDAs and tentatively approved 19 ANDAs in December – well, we were as close as we ever have been, estimating using numbers derived from various FDA statistical reports… and […]
To reiterate our post of December 27, 2017 (here), please start working on your one time report on the marketing status of your products listed in the Orange Book. The deadline is approaching and FDA even republished its advice to industry (here) again today! Don’t be left without a retort – be sure to submit […]
While OGD has not published the official numbers for December 2017, it appears from the FDA All Approvals list (here) that OGD fully approved 78 ANDAs and tentatively approved 19, for a total of 97 approval actions. While this is slightly lower than the previous two months of FY 2018, it is to be expected, […]
Today, the FDA issued a draft guidance entitled “Good ANDA Submission Practices” (here) along with a new Manual of Policy and Procedure (MaPPs) 5241.3, entitled “Good ANDA Assessment Practices: Manual of Policies and Procedures.” These establish good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their […]
It has been quite a while since FDA totally updated the class labeling guidance for combined hormonal contraceptives (CHC). FDA notes “this newer CHC labeling may be different from the labeling for some older CHC products. The updates to this guidance set forth labeling recommendations that represent newer class labeling that should be included in […]
After the glow of the holiday season, and after the big bowl games and national football championship, you better get the team prepared to file your one-time report of the marketing status of every one of your NDA and ANDA products. FDARA requires every firm to submit the one time written report telling FDA if: […]
It is interesting that the FDA provides reports of first generic approvals by calendar year, but activity by fiscal year. Today we will look at the last 5 calendar years of first approvals and try to make some assumptions of what these numbers reflect in the scheme of generic approvals in general. The chart […]
Here we are, at the end of another busy year. As a matter of fact, this blog is celebrating its 5th year of missives that we hope have provided you a different perspective into the world of FDA, along with some laughs along the way. It has been a pleasure sharing all the ups and […]
