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The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards. Read More
The FDA is working rapidly to establish a mutual inspection program with the EU that uses similar GMPs and quality metrics, CDER Director Janet Woodcock said June 1, adding that the current system of different expectations is not sustainable. Read More
Drugmakers are asking the European Commission to clarify new requirements for equipment used in the manufacturing process, including when it’s okay to test such equipment at the factory instead of on site. Read More
Members of the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-6 Thursday to recommend approval of Sprout’s female sexual dysfunction drug, despite lingering safety concerns. Read More
The UK’s healthcare cost regulator is asking BioMarin to provide more information on Vimizim, its treatment for the rare inherited disease Morquio A Syndrome, saying current evidence doesn’t support coverage of the drug. Read More
The European Commission will revise four annexes to its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More
Australia’s Therapeutic Goods Administration has adopted 10 EU guidelines, four that are new for the country and six that replace existing guidelines. Read More