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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


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


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