FDA Warns Chinese OTC Drugmaker
The FDA hit Hangzhou Guogang Touring Commodity, an OTC drug manufacturer in Zhejiang, China, with a warning letter, for significant problems with equipment cleaning and drug product conformity. Source: Drug…
FDA Extends Type III Drug Master File E-Submission Compliance Date Another Year
The FDA issued revised guidance on electronic submissions of drug master files, extending the timetable for Type III submissions by another year to May 5, 2020. Source: Drug Industry Daily
PCMA Says Competition Is Key to Lowering Drug Prices
Competition is the key to lower drug costs, the Pharmaceutical Care Management Association (PCMA) said in a letter to lawmakers in defense of pharmacy benefit managers. Source: Drug Industry Daily
Pharma Blasted in Congress for Manipulating Drug Prices
Drugmakers were conspicuously absent on Tuesday from two drug pricing hearings on Capitol Hill, where lawmakers called out big pharma for setting high drug prices through manipulative means — and…
NY Pharmacists: PBMs Hiked Generics Prices in Medicaid Managed Care Program
A New York pharmacist group claims the misuse of “spread pricing” by the state’s pharmacy benefit managers has led to increased drug prices – especially for generics. Source: Drug Industry…
PhRMA Pushes Back on CMS Plan to Increase Medicare Part D, Advantage Negotiating Power
PhRMA picked holes in a proposed Centers for Medicare & Medicaid Services rule increasing Medicare Advantage and Part D plans’ power to negotiate drug prices. Source: Drug Industry Daily
Gottlieb Touts FDA’s Plans for Real-World Evidence in Trials
FDA Commissioner Scott Gottlieb on Monday outlined the agency’s plans for promoting the use of real world evidence in clinical trials in 2019. Source: Drug Industry Daily
Controls Found Lacking at Contract Manufacturer Thatcher
Contract manufacturer Thatcher Company failed to exercise appropriate controls over computers and related systems to assure that changes in production were only instituted by authorized personnel, FDA inspectors found during…
Surgical Instruments Maker Racks Up 11-Item 483
Lax medical device reporting and CAPA procedures as well as a host of other quality issues were uncovered during a July 31 to Aug. 2 FDA inspection of LED Intellectual…
Texas Neonatal Devicemaker Falls Short on Process Controls
FDA inspectors found shoddy process controls and a lack of validation documentation in a Sept. 17 to Sept. 21 inspection of Footprint Medical’s San Antonio, Texas facility. Source: The GMP…