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Start Over You searched for: Subjects Drug Approval -- legislation & jurisprudence Remove constraint Subjects: Drug Approval -- legislation & jurisprudence
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1. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

nlm:nlmuid-101704838-pdf

2. Citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act

nlm:nlmuid-101760431-pdf

3. Prescription Drug User Fee Act waivers, reductions, and refunds for drug and biological products

nlm:nlmuid-101760538-pdf