Oklahoma OTC Manufacturer Cited for Multiple Violations
The FDA hit OTC drug manufacturer Tomco-Harwel Industries with an extensive Form 483 for numerous violations at its Tulsa, Oklahoma facility. Source: Drug Industry Daily
FDA Warns California OTC Drugmaker for Defective Products
The FDA issued a warning letter to Thibiant International for producing defective OTC drugs at its Newbury Park, California manufacturing facility. Source: Drug Industry Daily
Brexit Chaos Has Drug Regulators, Industry Living in Conditional Tense
UK lawmakers on Friday failed to approve an orderly withdrawal from the European Union, leaving drugmakers and regulators scrambling to make sense of the chaos. Source: Drug Industry Daily
Gottlieb Urges Drug Sponsors to Expand Access to Treatment After Trials
FDA Commissioner Scott Gottlieb and two of his top aides took to the internet Friday to urge drug sponsors to continue treatment for especially needy clinical trial patients after their…
EMA Reviews Two Decades of Drug Inspections
EU regulators flagged 18 percent of inspected biologics and nine percent of inspected drugs for scientific or regulatory problems in the two decades since European regulators began inspecting drugs and…
New York Files Detailed Suit Against Opioid Makers, Distributors
New York’s Attorney General Letitia James on Thursday joined the opioid fray accusing drugmakers and distributors—including Purdue Pharma and its owners, the Sackler family—of unleashing a “plague” that has killed…
Gottlieb Highlights FDA Efforts on Opioids in Senate Testimony
It was a lovefest for outgoing FDA Commissioner Scott Gottlieb on Thursday as he testified before the Senate Committee on Appropriations on the FDA’s budget request for fiscal 2020. Source:…
FDA Announces 2019 Initiatives For Device Safety and Innovation
FDA Commissioner Scott Gottlieb and CDER director Jeff Shuren announced plans to promote device innovation and safety in 2019 using new premarket pathways as well as new safety and performance…
EMA Issues Guidance on New Device, IVD Rules
The European Medicines Agency issued final guidance on new rules for certain in vitro diagnostics and medical devices. Source: The GMP Letter
FDA Increases Efforts to Flag Recalls
FDA Commissioner Scott Gottlieb announced that the agency is ramping up its efforts to improve recall notifications and public warnings. Source: The GMP Letter
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