12
Feb
An unhappy female student sitting on sofa, tearing paper when studying.

Regulatory Agendas for Various Agencies Disappeared from Federal Register

I guess this is the next step in the evaluation of what we can expect regarding proposals for future regulations.  Semiannual regulatory agendas, along with tentative timetables, are published twice a year (as the name implies) to outline regulations that each agency is planning on issuing for those regulations. Today, in the pre-publication of the […]

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06
Feb
What a Difference a Day Makes January 2025 Unofficial Numbers - Lachman Blog

What a Difference a Day Makes (at Least for Approval Information)! Well, Here Are January 2025 Unofficial Numbers

Powered up my laptop this morning and guess what I found? ANDA, NDA, and BLA approval actions had been updated from their last postings on January 22, 2025 after the pause on communications from the FDA. The best news is that January 2025 ANDA approval actions look great. As of today, the OGD has posed 64 […]

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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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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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10
Sep
U.S. and EU Drug Shortages - Lachman Consultants

New Risks Discovered as U.S. and EU Drug Shortage Efforts Start to Merge

U.S. and EU efforts to manage supply chain shortages are slowly converging; however, the political winds in the Rest of World (ROW) may be diluting required oversight.  Both the U.S. (Risk Management Plans to Mitigate the Potential for Drug Shortages | FDA) and EU (Shortage Prevention Plan (SPP) – template (europa.eu)) have published either a […]

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20
Aug
Science versus Compliance - Lachman Blog

Science versus Compliance?

Working in the pharmaceutical industry, you can sometimes hear science and compliance talked about as if they are separate and unrelated. Two examples of what can be heard: “Oh well, that is more of a compliance risk than a scientific concern.” “You need to consider the compliance aspect of that change and then the scientific […]

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