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The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act.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