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Titles
- ANDA submissions--amendments to abbreviated new drug applications under GDUFA1
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff1
- Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application1
- Orphan drugs: FDA could improve designation review consistency; rare disease drug development challenges continue : report to Congressional requesters1
- Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers1
- Quality attribute considerations for chewable tablets1
- S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers1
- Special protocol assessment1