12
Jun
Red apple with bite

Another Bite at the Apple!

Yesterday, U.S. Senators Markwayne Mullin (R-OK) and Cory Booker (D-NJ) reintroduced the “Prescription Information Modernization Act of 2025.”  You’ll likely remember that it has had quite a history.  It’s a commonsense bill that would allow firms to use electronic labeling, eliminating the requirement to include paper package inserts, better known as the prescribing information, while […]

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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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30
May
Is Your Stability Program Risk-Based - Lachman Blog

Is Your Stability Program Risk-Based?

On April 11, 2025, the ICH endorsed a draft guidance titled “Stability Testing of Drug Substances and Drug Products Q1” (here). This is a large, comprehensive guidance that applies to stability testing of chemically synthesized drug substances, biologics, vaccines, gene therapies, and combination products. The guidance addresses primary stability studies, commitment, ongoing and stability studies […]

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12
May
US Food and Drug Administration (FDA)

Priority Review Vouchers a Hot Commodity

Over the last eight months, a number of priority vouchers were sold by firms that were subject to the award of either a tropical disease priority review voucher, a rare pediatric disease priority review voucher, or a material threat medical countermeasure (MCM) priority review voucher.  The purchase prices of these vouchers, while not as high […]

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08
May
Technology artificial intelligence digital ai hand concept on cyber future business tech science innovation futuristic network strategy background virtual data communication learning assistant search.

AI Is Here for Reviewers as FDA’s Aggressive Agency-Wide AI Rollout Timeline Is Announced

The FDA completed its first AI-assisted scientific review pilot, which will provide reviewers with great opportunities for efficiency in the review process.  According to the FDA release (here), Dr. Makary said, “I was blown away by the success of our first AI-assisted scientific review pilot.  We need to value our scientists’ time and reduce the amount […]

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01
May
Note pad with word what? why? who? how? when? where?

BPDRs – Is Your Team Ready to Recognize the Need for One?

Biological Product Deviation Reports (BPDRs) are coming into increasing focus during FDA inspections.  The FDA commonly requests an understanding of a site’s BPDR process and examples of BPDRs submitted to the Agency.  Furthermore, during the inspection and during evaluation of distributed licensed product, FDA investigators will evaluate “How,” “Why,” and “When” a firm determines the […]

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30
Apr
FDA Total Reorganization - maybe not - Lachman Blog

FDA Total Reorganization? Maybe Not!

Talk has come fast and furious about a new, significant FDA reorganization with what looked like, as reported by PharmaVoice’s Amy Baxter (here), “five new shared services offices rather than the current product-based offices.” However, in an exclusive interview with Dr. Marty Makary that was conducted by Jeremy Faust, MD and reported in Inside Medicine (here), […]

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31
Mar
What’s a Body to Do - Lachman Blog

What’s a Body to Do?

Now that Dr. Marty Makary, MD, MPH, has been confirmed and appointed as FDA Commissioner, much of the Agency does not look the same. The morale at the FDA, from what I hear, is at an all-time low. And now, with reports of the reduction in workers’ safeguards along with actions as to what appears […]

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11
Mar
This Round of the Fight Goes to the FDA - Lachman Blog

This Round of the Fight Goes to the FDA

An Endpoints News story authored by Shelby Livingston titled “Compounders’ motion for preliminary injunction denied in case over tirzepatide shortage” (here; subscription needed) appears to give this round of the fight to declare the tirzepatide drug shortage over to the FDA. The Honorable Mark Pittman, U.S. District Court for the Northern District of Texas, denied […]

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