I have been attempting to compare backlog numbers, receipts of new ANDAs and applications that are in the hands of industry for response to FDA’s Complete Response Letters (CRLs), and it has been quite a struggle. But I think I’ve got it now, and I hope I am right! The way the “backlog” used to […]
We are not entirely sure how FDA makes its decisions to revise a BE Guidance document, but we are clearly in the dark as to how and when the FDA decision to require firms to repeat BE studies using the revised recommendation are made. I am sure that FDA will (as they have with certain products) tell a firm when it is absolutely necessary to repeat a study using a new BE recommendation, but FDA does not do this in all instances. What are the criteria for FDA’s decision making process?
In a Federal Register (FR) Notice published today, FDA indicates that it is seeking comments from the industry and the public on a potential user fee program to support an efficient over-the-counter (OTC) to support the OTC monograph review process. FDA notes that, while overall aspects of the drug, biologics and device review process […]
The Office of Generic Drugs (OGD) received 55 original ANDAs in April 2016, the third highest number of receipts in the 8 months of FY 2016. The two higher months were December 2015 (180) and March 2016 (114). OGD has received a total of 527 ANDA or an average of just a little over […]
The Office of Generic Drugs (OGD) fully approved (AP) 53 ANDAs and issued 16 Tentative Approvals (TAs) in the month of April. Thus far in FY 2016, OGD approved a total of 399 ANDAs averaging 57 a month-a 29% increase over FY 2015’s average of 41 a month. Tentative Approvals in FY 2016 total 109 […]
Well, not really-but on April 12, 2016 (my birthday), the FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER) gave a presentation (here) entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.” It is quite interesting to note that FDA has been actively involved in the regulatory […]
So you think you can always get a Q1/Q2 (qualitative and quantitative sameness) determination from the Office of Generic Drugs (OGD) through a Controlled Correspondence? Well, think again. Well, getting this information from FDA may be easier said than done.
It appears that if you wait long enough, things come full circle. Take, for instance, claims that some artificial sweeteners cause cancer, or that coffee was bad for you, or that chocolate only made you fat. Well, that appears to be in the cards for the Black Box warning on the smoking cessation drugs Chantix […]
Most of the pharmaceutical industry has issued White Papers, blogged, sent letters to FDA, and lobbied their trade associations over the FDA’s Proposed Labeling Rule that would permit generic manufacturers to unilaterally add safety information to their approved labeling. Even Congress is getting into the act in trying to derail the FDA’s proposal. The Proposed […]
In an unusual 12-0 vote, an FDA advisory panel recommended that the acne treatment adapalene gel 0.1% be switched to Over-the-Counter (OTC) use. If the FDA concurs, this will be another FDA approved product to join a number of OTC monograph products in the OTC market to treat acne.
