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Titles
- Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry1
- Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations1
- Best practices for convening a GRAS panel: guidance for industry1
- Cancer clinical trial eligibility criteria: available therapy in non-curative settings1
- Clinical decision support software: guidance for industry and Food and Drug Administration staff1
- Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry1
- Competitive generic therapies: guidance for industry1
- Compounding certain beta-lactam products in shortage under Section 503A of the Federal Food, Drug, and Cosmetic Act: immediately in effect guidance for industry1
- Computer-assisted detection devices applied to radiology images and radiology device data: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff1
- Cross labeling oncology drugs in combination regimens: guidance for industry1
- E14 and S7B clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential: questions and answers1
- E19: a selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials : guidance for industry1
- Electronic submission template for medical device 510(k) submissions: guidance for industry and Food and Drug Administration staff1
- Exemption and exclusion from certain requirements of the Drug Supply Chain Security Act for the distribution of FDA-approved naloxone products during the opioid public health emergency: guidance for industry1
- Failure to respond to an ANDA complete response letter within the regulatory timeframe: guidance for industry1
- Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry1
- General clinical pharmacology considerations for neonatal studies for drugs and biological products1
- Homeopathic drug products: guidance for FDA staff and industry1
- Human gene therapy for neurodegenerative diseases: guidance for industry1
- Infant formula enforcement discretion policy: guidance for industry1