It has been quite a while since FDA totally updated the class labeling guidance for combined hormonal contraceptives (CHC). FDA notes “this newer CHC labeling may be different from the labeling for some older CHC products. The updates to this guidance set forth labeling recommendations that represent newer class labeling that should be included in […]
After the glow of the holiday season, and after the big bowl games and national football championship, you better get the team prepared to file your one-time report of the marketing status of every one of your NDA and ANDA products. FDARA requires every firm to submit the one time written report telling FDA if: […]
It is interesting that the FDA provides reports of first generic approvals by calendar year, but activity by fiscal year. Today we will look at the last 5 calendar years of first approvals and try to make some assumptions of what these numbers reflect in the scheme of generic approvals in general. The chart […]
FDA published a Final Rule (here), finding that 24 ingredients in the proposed monograph, “Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” are not considered, or generally recognized, as safe and effective (GRAS/GRAE) for OTC use. However, as noted in the Rule, the FDA has deferred regulatory action on 6 active ingredients: […]
In response to a petition denial, Docket No. FDA-2015-P-5081, asking the Agency to have products labeled with gluten content (here), the FDA has nonetheless issued a guidance document entitled “Gluten in Drug Products and Associated Labeling Recommendations”, wherein the Agency is permitting firms to add a statement to labeling regarding gluten, based on certain criteria. […]
The labeling for approved antifungal and antimicrobial prescription drug products contains certain language regarding the susceptibility test interpretive criteria (STIC) and associated test methods and quality control standards, with associated references for antimicrobial drugs for the specific compound. Many approved drug products have been around for a long time and the information regarding the STIC […]
Yesterday, the FDA published a draft guidance document titled Refuse to File: NDA and BLA Submissions to CDER (here). It covers NDAs and BLAs submitted to the Center for Drug Evaluation and Research. Unlike the long laundry list of issues that could result in a refuse-to-receive (RTR) determination for an 505(j) (ANDA) application, this guidance […]
In a recent guidance issued by FDA entitled Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements (here), the Agency provides current guidance on the various aspects of proprietary and established names in advertising. The document clarifies the relationship between the size (and not type size) of the proprietary name and established name […]
The Association for Accessible Medicines (AAM) has penned a letter (here) to the FTC, providing comments requested by that Agency relating to the Public Workshop held by FTC, Understanding Competition in U.S. Prescription Drug Markets: Entry and Supply Chain Dynamics, held November 8, 2017 in Washington, D.C.. AAM (formerly the Generic Pharmaceutical Association [GPhA]) highlighted […]
Well, we got the official November full ANDA approval numbers at 84 (previously reported here ), but we missed on the tentative approvals, which came in at a whopping 23 for a total of 107 approval actions. This is the second month in a row with greater than 80 approvals. In addition, for the second […]
