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...

FDA Testosterone Panel Sparks Concern

by Bruce Waldon | Dec 18, 2025 | Consumer Information, Consumer Safety, FDA Policy, FDA Public Information, Hormones, Industry Information, Industry News, Pharmaceuticals, Product Safety, Products_Drugs, US-FDA

Sudden Regulatory Shift FDA testosterone panel recommendations spark concern Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers Concerns Over Sudden Regulatory Shift The FDA’s...

Testosterone Regulation Takes a Sharp Turn

by Bruce Waldon | Dec 18, 2025 | Alerts-Pharma, Analysis, Consumer Information, Consumer Safety, Editorial, FDA Policy, FDA Regulations, Hormones, Industry Information, Industry News, Product Safety, Products_Drugs, Regulatory_Info

Testosterone Regulation Takes a Sharp Turn Why FDA’s December panel raises red flags Home Request Info QMSR Central QMSR FAQs ISO 13485 Transition Impact Integration Definitions FDA and ISO 13485 ISO 9000 Small Manufacturers Why FDA’s December Panel Raises Red Flags...

FDA “PreCheck” Program to Boost U.S. Drug Manufacturing

by MDP Staff | Aug 7, 2025 | FDA Public Information, FDA_Innovation, Industry Information, Industry News, New Pharma Products, Pharmaceuticals

“PreCheck” Program to Boost U.S. Drug Manufacturing Program supports facilities certification and drug submissions Home About Consumer Medical Devices Medical Device Warning Letters Pharma Pharma Warning Letters Biologics Biologics Warning Letters AI Regulatory...

FDA Cracks Down on Illegally Marketed 7-OH Products

by MDP Staff | Jul 16, 2025 | Alerts, Alerts-Pharma, Consumer Safety, FDA Warning letters, Industry News, Unapproved Drugs

FDA Cracks Down on Companies Illegally Marketing 7-OH Products Products that contain 7-hydroxymitragynine (7-OH) Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Unapproved drugs sold online and...