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Republican House members introduce legislation to combat prescription drug abuse through partnerships between industry, retail and government. Read More
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
The FDA is proposing to extend new chemical entity (NCE) market exclusivity for certain fixed-dose combination (FDC) drugs from three to five years, bowing to industry and congressional demands that more incentives are needed to pursue the costly products. Read More
After operating its OTC drug review process largely unchanged for 40 years, the FDA has concluded the process needs an overhaul to address long-standing problems. 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