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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
AbbVie filed a citizen petition Wednesday urging the FDA to establish clear and transparent labeling requirements for biosimilars, saying this will avoid potentially unsafe substitution of the products and their reference products. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More