December 2017

19
Dec

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: […]

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18
Dec

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 […]

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18
Dec

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 […]

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14
Dec
Don’t be a Glutton When It Comes to Gluten Image

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, based on certain criteria. […]

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13
Dec
STIC it to Me! FDA Says Image

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 […]

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12
Dec

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, this guidance […]

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12
Dec

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 […]

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