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The FDA invited comments on a draft guidance that outlines what the agency considers best practices for postmarket safety surveillance for drugs and biologics. Read More
The FDA has begun the second phase of its CDER reorganization efforts aimed improving drug reviews, including three new offices to handle medicines for cancers, infectious diseases and neurological disorders. Read More
The agency said further confirmatory testing should be conducted on products that are at risk of being contaminated with the potential carcinogen. Read More
A coalition of HIV advocacy groups challenged an attempt by Gilead Sciences to get out of a federal lawsuit against HIV drugmakers accused of delaying competition from generics and branded products. Read More