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Start Over Genre Guideline ✖ Copyright Public domain ✖ Publication Year 2022 ✖

21. Instructions for use: patient labeling for human prescription drug and biological products : content and format

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Government Regulation
Prescription Drugs
Product Labeling
United States
United States. Food and Drug Administration

22. Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2022
Subject(s):: Administration, Oral
Drug Approval
Drugs, Investigational
Food-Drug Interactions
Government Regulation
United States
United States. Food and Drug Administration

23. 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 staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 28, 2022
Subject(s):: Diagnosis, Computer-Assisted
Device Approval
Government Regulation
Radiographic Image Interpretation, Computer-Assisted
United States
United States. Food and Drug Administration

24. Clinical decision support software: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 28, 2022
Subject(s):: Clinical Decision-Making
Decision Making, Computer-Assisted
Government Regulation
United States
United States. Food and Drug Administration

25. 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 industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Government Regulation
Legislation, Drug
Naloxone -- supply & distribution
Opioid Epidemic -- prevention & control
United States
United States. Food and Drug Administration

26. Competitive generic therapies: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
United States. Food and Drug Administration

27. Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Group Processes
United States
United States. Food and Drug Administration

28. Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration

29. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Subject(s):: Device Approval -- legislation & jurisprudence
Government Regulation
Product Surveillance, Postmarketing
United States
United States. Food and Drug Administration

30. Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Subject(s):: Clinical Studies as Topic
Device Approval
Government Regulation
United States
United States. Food and Drug Administration