14
Jan
Speed Limit 45 Radar Enforced road sign with passing cars on a California street.

The FDA’s Spotlight on CDER Science – Nitrosamines and the Acceptable Intake Approach

In the latest CDER Science Spotlights, available (here), the FDA provides some insight into the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine recommended acceptable intake limits of N-nitrosamine impurities in drug products.  The latest revision of the Nitrosamine Impurity guidance updated in September 2024 (here) provided better integration of the overall assessment […]

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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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03
Jan
Testing substances

FDA Issues Draft Guidance to Assist in Compliance with 21 CFR 211.110

The Code of Federal Regulations at 211.110 is titled “Sampling and testing of in-process materials and drug products.”  This new draft guidance, issued by the FDA, is designed to assist drug product manufacturers in complying with this section of the regulations “to ensure batch uniformity and drug product integrity.  In addition, this guidance discusses related […]

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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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01
Nov
Female biologist testing the oxygen levels in the river

Water Conductivity Testing: More Than a Simple Test

Water is a critical component used in the manufacture of pharmaceutical products, and it must meet specific quality standards in order to demonstrate that the water intended to be used for manufacture is suitable for its intended purposes.  USP <1231> on Water for Pharmaceutical Purposes provides an overview of the different water types used in manufacturing, […]

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31
Oct
young professional who is writing down math formulas

Are Your Methods Fit for Purpose?

When addressing the requirements of analytical test procedures, 21 CFR 211.160 states: “Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.” 21 CFR […]

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25
Oct
The FDA Commissioner Takes a Seat with AAM on the Final Day of GRxBiosims Conference - Lachman Blog

The FDA Commissioner Takes a Seat with AAM on the Final Day of GRx+Biosims Conference

On the last day of GRx+Biosims, David Gaugh, Executive Vice President of AAM, had a fireside chat with Robert Califf M.D., commissioner of the Food and Drug Administration. The Commissioner’s comments echoed many of the themes discussed by other industry and FDA participants during the meeting, especially regarding the worry about sustainability of the generic […]

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