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Titles
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter1
- Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter1
- Recommended statement for over-the-counter aspirin-containing drug products labeled with cardiovascular related imagery1
- Recurrent herpes labialis: developing drugs for treatment and prevention1
- Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)1
- Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff1
- Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff1
- Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy1
- Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception1
- Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff1
- Sunscreen: FDA reviewed applications for additional active ingredients and determined more data needed : report to Congressional committees1
- Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs1
- Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff1
- The prohibition of distributing free samples of tobacco products1
- Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff1
- Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff1
- Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components1
- Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system1