On February 9, 2026, the FDA approved modifications to the Risk Evaluation and Mitigation Strategy (REMS) program for the safe use of isotretinoin. The REMS program has undergone various changes since its initial inception in 2005. The shared program (brand and generic applicants) is designed to mitigate the risk of fetal toxicity from isotretinoin. The current […]
The gauntlet has been laid down and now it’s also been run through the FDA and courts will tell the tale. With Novo Nordisk’s (Novo) suit against Him and Hers, the issue of 503B outsourcing facilities compounding of copies of FDA-approved products may hang in the balance. FDA has apparently taken a hard line on […]
Today, the FDA again advised consumers to avoid purchasing and using Umary, a product marketed as a dietary supplement to treat pain; it contains the undeclared prescription drug ingredients diclofenac and omeprazole. The Agency first warned consumers about this product and another, similar product marketed as Amazy in June 2024 and reissued that warning in […]
Since their introduction to the public in 1979, spreadsheets have come a long way. Even while technology has changed, from Apple II computers to artificial intelligence, spreadsheets have had incredible staying power. Nevertheless, spreadsheets struggle to keep pace with GxP requirements. In regulated companies, required to adhere to GxPs, spreadsheets can be useful, but they are […]
The FDA takes the next step with the PreCheck Pilot Program by providing a diagrammatic depiction of how it views selection for participation in the program will play out. The program is designed to effectuate Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs the FDA to “streamline review of domestic […]
When your company receives notification from the FDA that your most recent inspection is classified as “VAI” (Voluntary Action Indicted), does that mean that you’re off the hook and can relax until the next inspection? Absolutely not! The assignment of VAI spans the spectrum from almost NAI (No Action Indicated) (maybe one minor FDA Form 483 (483) […]
The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) endorsed a new draft guidance on extractables and leachables in August 2025 that the FDA has since published for review and comment. The version published by the FDA is accessible at Q3E Guideline for Extractables and Leachables and includes Supporting Documentation: […]
Why Using Full-Scale Deflection Introduces Data Integrity Risks In pharmaceutical manufacturing, Accuracy is a critical ALCOA+ principle that can sometimes get lost, particularly when assessing the holistic system. The field instrument level needs to be adequately integrated into the overall assessment, especially in aseptic manufacturing environments where sterilization is critical (and accurate data, such as […]
The concepts of Speak Up and Quality Culture have received renewed attention with recent developments of the European Union’s Artificial Intelligence Act. Lachman recently blogged about the importance of a healthy quality culture (Speak Up! Does Your Quality Culture Have a Voice?), and new proposals under the Digital Omnibus package in the EU introduce three […]
The life-sciences industry has long been synonymous with high barriers to entry. Traditional research and development (R&D) models demand enormous capital investment, specialized infrastructure, and a deep understanding of regulatory compliance. For startups and innovators, these requirements often translate into years of fundraising and risk before a single product reaches the market. However, the emergence […]
