Remember the problem associated with the evergreening of patents, which was the practice of obtaining and listing newly issued patents sequentially, and the resultant multiple 30-month stays that essentially kept generics off the market for prolonged periods of time?
FDA today released a draft Guidance document entitled, “Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.”
The month of April 2015 saw the largest number of ANDA approvals since the implementation of GDUFA, with 48 ANDA full approvals and 19 tentative approvals (TAs).
The FDA has published a Federal Register Notice announcing the reopening of the administrative record on the Tentative Final Monograph (TFM) for Topical Antimicrobial Drug Products for Over-the-Counter Human Use.
The FDA has published a revised listing of its new Guidance agenda for 2015 with a number of additions.
The Office of Generic Drugs (OGD) posted its latest paragraph IV listings and, while there was only one new addition to the list, that product caught my attention.
In the Federal Register today, FDA announced a public meeting to be held on June 15, 2015 at the FDA’s White Oak campus. The purpose of the meeting is to get the public’s input on the potential reauthorization of the Generic Drug User Fee Act (GDUFA).
The FDA is warning about some counterfeit Botox that has been found in the United States. The product looks similar to the brand name product but “[B]oth the outer carton and vial on the suspect product are counterfeit.
The date to comment is being extended to June 8, 2015, based on requests from the industry for more time to digest the Rule.
There are so many issues covered by the Proposed 505(b)(2) and ANDA Rule that we can fill a book with the explanations (and we almost have). But we are giving you the Readers Digest condensed version in these posts. Be certain to read the entire Proposed Rule and watch for comments on Regulations.gov to get an idea of which sections will provide more controversy than others.
