One-Time Report on Marketing Status Required by FDARA – Are You Ready?

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:

  1. the NDA or ANDA holder’s drug(s) in the active section of the Orange Book are available for sale;

First Time Generic Approvals 2013-2017


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.

Final Rule on Surgical Scrubs, Preps, and Hand Washes for OTC Use – Well, Almost!

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: benzalkonium chloride,

Homeopathic Drugs- Home for the Holidays or Not?!

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 a result of the Agency’s evaluation,

Janis Picurro, new Principal Consultant at Lachman Consultant Services, Inc.

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 Affairs.

Don’t be a Glutton When It Comes to Gluten

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,

STIC it to Me! FDA Says, “You Have One Year to Do It”

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 in their labels are outdated. 

RTR for NDAs and BLAs Submitted to CDER

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,

Size Does Matter!

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 in running text in advertisements and promotional material where the established name must be at least one-half the actual size of the proprietary name. 

AAM Letter to FTC – Issues Impacting Generic Access and Competition

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 several areas of concern in their comments:

  • According to AAM,

FDA Provides Interesting Enforcement Information

FDA posted Donald Ashley’s, Director of the Office of Compliance (OC), presentation (here)   at the FDLI Enforcement, Litigation, and Compliance Conference presented December 6, 2017.  Mr. Ashley provided some interesting enforcement information, some of which is presented here.

The FDA’s Biomedical Monitoring (BIMO) program warning letters issued over the last 4 fiscal years is captured in the slide below.

New Metrics and Format for OGD Stats, Just Filled in For October 2017

The new statistical report of the Activities of the Generic Drug Program (FY 2018) Monthly Performance (here) was posted on December 4, 2017. There are many new statistics being captured and to tell the truth I am not sure exactly what they all mean but I think I’ve got it straight.  Please take a look at the above report and if you disagree with my reading on any of these metrics please give me a shout out.

November Another Big Month for OGD Approval Actions

Based on the FDA’s All Approvals list (here), by my count, it appears that November was another good month for FDA approval actions.  Looks like OGD will report at least (we know that until OGD publishes its official numbers, this is just an estimate) 84 full approvals and 15 tentative approvals for a total of 99 (just 2 less than last month’s all-time high monthly total of 101 during all GDUFA).