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Titles
- ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs1
- Competitive generic therapies: guidance for industry1
- Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)1
- Determining whether to submit an ANDA or a 505(b)(2) application1
- Examining two approaches to U.S. drug pricing: international prices and therapeutic equivalency1
- Generic drugs: FDA should make public its plans to issue and revise guidance on nonbiological complex drugs : report to Congressional requesters1
- Generic medications: what you get is premium quality at a preferred price1
- Orange Book: questions and answers1
- Protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 public health emergency1
- Quality attribute considerations for chewable tablets1
- Referencing approved drug products in ANDA submissions1
- Safety and performance based pathway: guidance for industry and Food and Drug Administration1
- The Special 510(k) Program: guidance for industry and Food and Drug Administration staff1
- Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system1