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 […]
Here we are, at the end of another busy year. As a matter of fact, this blog is celebrating its 5th year of missives that we hope have provided you a different perspective into the world of FDA, along with some laughs along the way. It has been a pleasure sharing all the ups and […]
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: […]
Those homeopathic drug products for which no determination that the product is a new drug may be marketed under the Federal Food Drug and Cosmetic Act. However, given the current burgeoning homeopathic market, the FDA held a public hearing on March 27, 2015 to seek comments on its current regulatory framework for such products. “As […]
We are pleased to announce that Janis Picurro has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective December 18, 2017. Ms. Picurro is a senior level regulatory professional with over 24 years of experience in the pharmaceutical industry where she had a career of progressively increasing responsibilities in Regulatory […]
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 […]
