04
Jun
Minor Dosage Form Changes - Lachman Blog

Minor Dosage Form Changes to OTC Monograph Products Contemplated by Draft FDA Guidance

Today, the FDA published a draft guidance titled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (here). This document discusses the conditions under which minor changes in dosage form (i.e., tablet or capsule to chewable tablets, orally disintegrating tablets (ODT), […]

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03
Jun
Do More with Less - Lachman Blog

Do More with Less – Looks Like That Is What the FDA Budget Request Asks

Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.” What a dandy, […]

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20
May
Close up of man having itch caused of a red rash

Scratch My Itch

The FDA warns about the potential for rare but severe itching after discontinuation of cetirizine or levocetirizine for both over-the-counter (OTC) and prescription drug products (here).  The FDA says, ”[t]he itching, also called pruritus, has been reported in patients who used these medicines daily, typically for at least a few months and often for years. […]

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13
Mar
The Benzene Frenzy - Lachman Blog

The Benzene Frenzy: FDA Testing Reveals that the Extent of the Issue Appears Much More Limited Than Previously Thought

After a March 6, 2025 report from an independent testing facility claimed that a significant number of acne products containing benzoyl peroxide were found to have very high levels of benzene (here), the threat has been countered by the FDA’s own testing of 95 products. After the FDA’s testing results were confirmed, it announced that the “FDA […]

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25
Feb
Is the Freeze Beginning to Thaw - Lachman Blog

Is the Freeze Beginning to Thaw?

There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]

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08
Jan
The Promise of ACNU A New Era in Self-Care and Market Innovation - Lachman Blog image

The Promise of ACNU: A New Era in Self-Care and Market Innovation

The pharmaceutical industry is entering a transformative era with the Food and Drug Administration’s (FDA) newly established pathway for nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU), with the final rule announced in a December 2024 Federal Register Notice (here). This new rule aims to broaden consumer access to safe and effective […]

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19
Dec
Generic Drug Cluster Has a Lot of Muster - Lachman Blog 2

Generic Drug Cluster Has a Lot of Muster!

The Generic Drug Cluster is a consortium of top regulatory agencies from around the world that get together to discuss common issues related to the drug approval process in an effort to better understand how each agency approaches various topics. Hopefully, these discussions will result in developing regulatory strategies that reflect the best and most […]

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03
Dec
Quick Reminder for Hand Sanitizers Manufacturers - Lachman Blog image

Quick Reminder for Hand Sanitizers Manufacturers – Important Date Coming Up!

For certain “companies that first registered with the FDA during the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE were not identified as facilities subject to the OMUFA facility fee, for a certain time period. That time period, which extended beyond the end of the PHE, […]

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26
Nov
Warning message

FDA Updates Warning for All NSAIDs; Other Drugs to Come?

For those of you who follow the daily approvals page (here), on November 21, 2024, there was a flurry of supplemental labeling approvals listed for drug products that contain non-steroidal anti-inflammatory drugs (NSAIDs), from aspirin to Zipsor (diclofenac potassium).  In today’s CDER Drug Safety-related Labeling Changes (SrLC), the new, revised warning that must be included was […]

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