When Randomized Trials Are Not Possible

by Bruce Waldon | Mar 10, 2026 | Clinical, Industry Information, Industry News, Research

FDA Regulatory Innovation The role of real-world evidence in drug approvals Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact...

FDA Approves Cerebral Folate Transport Deficiency Treatment

by Bruce Waldon | Mar 10, 2026 | FDA_Innovation, Industry Information, Industry News, New Drugs, Pharmaceuticals, Product-Innovation, Products_Drugs, US-FDA

FDA Pharmaceutical Innovation Expanded use of Wellcovorin (leucovorin calcium) tablets Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts...

FDA Program to Accelerate U.S. Pharmaceutical Manufacturing

by Bruce Waldon | Mar 4, 2026 | Industry Information, Industry News, Pharmaceuticals, US-FDA

FDA's Precheck Pilot Program Designed to stimulate US-based pharma manufacturing Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Launches “PreCheck”...

FDA Issues 30 Warning Letters to Telehealth Firms

by Bruce Waldon | Mar 4, 2026 | Compounding Labs, Drug Warning Letters, Industry Information, Industry News, Pharmaceutical Labeling, Pharmaceuticals, Telehealth, US-FDA

MDP Regulatory Insight FDA warns about compounded GLP-1 marketing claims Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Issues 30 Warning Letters to...

FDA Warning Letter Cites Key CGMP and Data Integrity Failures

by Bruce Waldon | Mar 2, 2026 | Drug Warning Letters, Industry News, Pharmaceuticals

MDP Regulatory Insight Serious failures cited for drug and homeopathic products manufacturer Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Warning...

FDA Approves First Generic Fenbendazole Oral Suspension

by Bruce Waldon | Jan 22, 2026 | Products - veterinary, Veterinary, Veterinary Science

First Generic Fenbendazole Oral Suspension for Cattle and Goats FDA grants full approval based on bioequivalence Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation...