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The FDA issued draft guidance on when CDER may refuse to file new drug applications and biologics license applications, outlining errors or omissions that can lead them to classify the application as incomplete. Read More
The Senate’s health committee held its final hearing in a set of three this year on the rising costs of prescription drugs — this time exploring how value-based pricing could help make payments more efficient, although it brings its own set of challenges. Read More
The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act. Read More
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
Most drugmakers are fulfilling their postmarketing study commitments, but many are not meeting their deadlines for annual status reports, the FDA said. Read More