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The FDA handed Mexican drugmaker Degasa a Form 483 with 12 observations listing the many noncompliance issues found during an inspection of its Jiutepec, Morelos facility, including faulty recordkeeping, inadequate testing and poor quality controls. Read More
The European Medicines Agency released a draft revised guideline for safety and efficacy follow-up of advanced therapy medicinal products, including gene therapies, cell therapies and tissue engineering. Read More
Teikoku Pharma reached an agreement with 22 state attorneys general to end a lawsuit accusing the drugmaker of obstructing generic competition. Read More
The FDA is working with providers, manufacturers and distributors to head off potential saline shortages during flu season, FDA Commissioner Scott Gottlieb said Thursday. Read More
Three supermarket chains sued more than 20 generic drug manufacturers, including Actavis, Apotex, Mylan, Teva and Sandoz, alleging they engaged in a conspiracy to set prices. Read More