Although the generic industry has come a long way in terms of Quality-by-Design or the desired space, it is still in early stages when it comes to Dates and Abbreviations as they relate to GDUFA. It has been a little overwhelming to the participants of this year’s Association of Accessible Medicines (AAM) Fall Technical Conference […]
I was lucky enough to moderate the panel on the Priority and Expedited Review with panel members Scott Tomsky and Kurt Karst at the Association for Accessible Medicines (AAM) on November 8, 2017. You all know them and it was interesting that the three of us were, without a doubt, on the same page. What […]
Lots of topics have been discussed on the first two days of the Association for Accessible Medicines (AAM) Fall Technical Conference. Many of the detailed presentation and speakers’ comments had what I refer to as hidden gems that might have escaped full view. Here are some of the noteworthy tidbits: What about those ANDAs that […]
Giuseppe Randazzo, the Director of the Office of Program and Regulatory Operations, urged the generic industry to tell a story in a cover letter when sending a submission to FDA. Yes, that’s right. At his presentation in Bethesda at the Association of Accessible Medicines 2017 Fall Technical Conference, Mr. Randazzo explained that a cover letter, […]
My previous guest blog post, “Taking Care of Our Neighbors” (here), was focused on improving the health of uninsured, low income Americans, and the Dispensary of Hope’s incredible collaborative network. Today, my mind is on the need for a change in our economic perspective as it relates to improving the health of our uninsured friends, […]
If you have been reading my blog regularly, I guess I have gotten much of the reading of the wind correct because there was not a lot of new information in Cook’s (Kathleen Uhl M.D., Director, Office of Generic Drugs) talk at this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda, MD. […]
The FDA today posted a revised draft guidance (here) on the Pre-submission Facility Correspondence (PFC) required to gain a priority review under GDUFA II. We previously reported on the initial draft guidance here and did not think it could get worse — but apparently we were wrong. Many in the industry have complained that with […]
While we are currently waiting for the official statistics for the approval actions for the first month of GDUFA II, a review of the FDA All Approvals List (here) for that month gives us encouragement. It appears that OGD has approved about 84 ANDAS and tentatively approved 13 ANDAs. These numbers may go up a […]
