After just over five years, the FDA is officially withdrawing its controversial proposed labeling rule for generic drugs. The advance publication notice in the Federal Register can be found (here). The proposed rule would have permitted ANDA holders to unilaterally revise its labeling via a CBE-0 supplement to include new or different safety information or warnings.
While we had underestimated approvals and slightly overestimated Tentative Approvals in our November 1 post (here) on this topic, nevertheless, OGD beat the old record of 126 for total approval actions in a month by 2. OGD fully approved 110 ANDAs and tentatively approved 18 ANDAs for a total of 128 ANDA approval actions starting off FY 2019 with a bang!
Although the Office of Generic Drugs (OGD) has not yet released the official approval numbers for October 2018 (which is the first month of FY 2019, and the first month of GDUFA II), it appears that a new record will be set. OGD approved 101 ANDAs, and tentatively approved 21 ANDAs for a total of 122 approval actions for the month;
While the FDA does appear to listen rather intently to comments on its bioequivalence (BE) draft guidances, and will occasionally reopen comment periods, it is still the exception rather than the rule. Today a Federal Register (FR) notice (here) announced another sixty-day comment period during which such comments will be entertained.
In a time that we find ourselves so busy, who has time to attend a conference? That was my initial thought, but when asked to speak at the conference, it became clear that this would be a unique opportunity to better understand the regulatory landscape while surrounded by members of India pharma and in the presence of key FDA regulators.
Today FDA announced finalizations in two guidance documents for transdermal systems (TDS) one relative to skin adhesion studies (here) and one related to skin irritation and sensitization studies (here). The revisions to the previous drafts came after FDA considered a number of industry comments to those drafts.
The Complex Generic Drug Development Workshop is currently being held in Silver Spring, Maryland September 12‑13, 2018. In her keynote address at the FDA’s Small Business and Industry Assistance (SBIA) workshop on complex generic drug development, Kathleen Cook Uhl stated that complex drug products are critical to the care of many serious medical conditions, such as multiple sclerosis,
The GRx+Biosims Conference held in Baltimore, MD from September 5-7, had a session on the GDUFA II Pre-ANDA Program for Complex Products on the last day, presented by FDA.
The presenter, Kris Andre, Associate Director of Regulatory Affairs, Office of Research and Standards, Office of Generic Drugs (OGD), discussed in detail the logistics and agency’s expectations related to the meetings for complex generics.