Industry does not always get either the filing type or the need to file the change correct and, sometimes, due to an overabundance of caution, makes supplemental submissions when they may be able to either report the changes in an Annual Report or may not need to report the change at all, but manage it under their Pharmaceutical Quality System (PQS).
Industry has been dealing with deciding which post-approval changes need to be reported to FDA, based on a series of Guidance documents (i.e., SUPAC-IR, the three Changes to Approved Application documents, CMC Post-Approval Changes to be Documented in Annual Reports) and, of course, the regulations at 21 CFR 314.70 and 601.12. Industry does not always get either the filing type or the need to file the change correct and,
Since my post yesterday, a number of readers pointed out that the DMF assessment requirement as a basis for Refuse-to-Receive file determination has been removed from the previous guidance. I concur that is the case, and there are and may be multiple reasons for its removal.
The newly revised Refuse-to-Receive (RTR) Guidance for ANDAs was issued on May 26, 2015 and was published on the FDA website the same day.
There are certain products that must be Q1 (qualitatively) and Q2 (quantitatively) the same, in terms of active and inactive ingredients, in order to avoid having to conduct in vivo pharmacokinetic or bioequivalence studies with clinical endpoints.
The FDA posted its activity associated with the some unregistered wholesalers that target doctors’ offices and clinics offering discount drugs. In addition, FDA has sent letters to doctors and clinics that may have purchased counterfeit or unapproved drugs.
With June 15th quickly approaching, the industry is preparing to discuss the progress under GDUFA I with FDA while also being able to extol the successes and shortcomings of the first iteration of GDUFA.
As we reported in October of 2014, the FDA announced that it was proposing to conduct a study of pharmacist and patient perception of changes in the physical attributes of generic products.
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FDA today released a draft Guidance document entitled, “Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics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).