We got close when we reported the unofficial OGD approval actions (here) at seventy-seven and thirteen – well, the OGD’s official numbers were seventy-eight full-approval actions (the highest since May 2019) and fifteen tentative-approval actions for a total of ninety-three. The OGD reports that nine of the seventy-eight full-approval actions were for first-time approvals. Good way to […]
So today, FDA posted minutes of its October 29, 2020 GDUFA III negotiation meeting with industry. Nice to see that the FDA is keeping us informed of pertinent issues being discussed. Here is the entirety of the minutes absent the attendees and the date of the next meeting. Discussion Industry provided their response to FDA’s […]
Well, here we are, at the end of the conference already. Let us look at highlights of the Day 3 activities. Dr. Alex Azar, Secretary of Health and Human Services, gave the opening keynote address and, in usual fashion, he thanked the generics and biosimilar industries for making high-quality generic drugs and biosimilars available to […]
Some of the afternoon sessions at AAM shone the light on approaching development of complex drug products including drug/device, topicals, ophthalmic products, and orally inhaled products. Each session provided a treasure trove of information regarding the specific dosage forms and issues that the agency and industry has had to deal with. To cover it all […]
Another day, another early morning on the West coast. While I am an early riser, 5:30AM is even a chore for this old FDA-er! But here we go! The morning began at the AAM GRx-Biosims meeting with Dr. Sally Choe, Director of the Office of Generic Drugs, as she provided a current program summary. We […]
We all know you can’t be in two places at once (although it would certainly be handy at times). That applies to the Association for Accessible Medicines (AAM) meeting as well. While there are lots of good sessions, as a one-man band, some tough choices had to be made. Let’s tackle one of the most […]
While there is nothing like being together, the COVID pandemic has kept us apart and so it is for the AAM conference. Getting used to the format was easy but it ain’t the same! While there were some minor technical glitches, the conference went off without a major hitch. Dan Leonard, the new President and […]
On November 11, 2020, Lachman’s Scott Deckebach MBA, Director, Compliance, Lachman Consultants will be participating in a panel discussion during the 2020 Bio/Pharma Virtual Congress, “‘New Normal’ for Quality Practices”. This discussion will review quality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes […]
The FDA updated the full FY 2020 stats sometime overnight and now we have a clear picture of how the FY shaped up. While it is not somewhere over the rainbow, it appears to be the new normal and that’s not too bad. Let us take a look! First, the Refuse-to-Receive (RTR) numbers are down […]
Answer: Who is Bob Pollock? Next week, November 9-11, the Association for Accessible Medicines (AAM) will be hosting a virtual version of the GRx+Biosims conference. As a part of it, an Orange Book Jeopardy was held between 3 Orange Book virtuosos: Kurt Karst of Hyman, Phelps & McNamara, David Rosen of Foley Lardner, and our […]
