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Titles
- Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Development of abbreviated new drug applications during the COVID-19 pandemic: questions and answers1
- Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry1
- Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff1
- Drug products, including biological products, that contain nanomaterials1