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Sponsors should use Extensible Markup Language (XML), not Standard Generalized Markup Language (SGML) when transmitting reports about patient reactions in clinical trials, under an FDA final guidance adopted Friday. Read More
In a decision that expands Sovaldi’s market dominance, the European Medicines Agency (EMA) Friday approved compassionate use of the Gilead drug with ledipasvir to treat patients with hepatitis C genotype 1. Read More
Troubled drug compounder and repackager Medisca has landed in hot water with the FDA again after the agency found a different type of drug in recalled lots of L-citrulline. Read More
Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP, after a single glass particle was found in just one vial of a lot of the drug. Read More
Chinese inspectors will focus their reviews on production technologies, raw materials, adverse event reports and a company’s past inspection track record when they conduct quality inspections. Read More
The FDA is currently recruiting and training seven investigators for its India office, growing the agency’s in-country American staff acting from 12 to 19. Read More
Drugmakers should clearly define their validation activities in a validation master plan that accounts for the lifecycle of a product and related plant equipment, the European Commission says. Read More
Israeli-owned RedHill Biopharma and Canada’s IntelGenx have received a complete response letter from the FDA for their RHB-103 migraine drug, which cites problems with the pharma partners’ third-party chemistry, manufacturing and controls, packaging and labeling issues. Read More
The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
The EU’s new pharmacovigilance law could cost drugmakers fees totaling as much as $330,000 for each drug they make to cover postmarketing assessments. The EU proposed the fees, divided into two categories, Thursday as a way to pay for the reviews mandated under the 2010 law. Read More