Subjects: United States. Food and Drug Administration / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects United States. Food and Drug Administration ✖ Genre Guideline ✖

31. 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

32. 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

33. 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

34. 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

35. Infant formula enforcement discretion policy: guidance for industry

Publication:: College Park, MD : Center for Food Safety and Applied Nutrition, May 2022
Subject(s):: Food Supply -- legislation & jurisprudence
Government Regulation
Infant Formula -- legislation & jurisprudence
United States
United States. Food and Drug Administration

36. Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Capsules -- standards
Drugs, Generic -- standards
Government Regulation
Tablets -- standards
United States
United States. Food and Drug Administration

37. S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
Subject(s):: Carcinogenicity Tests -- standards
Drug Evaluation, Preclinical
Government Regulation
United States
United States. Food and Drug Administration

38. Regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps): small entity compliance guide : guidance for industry

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

39. Human gene therapy for neurodegenerative diseases: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2022
Subject(s):: Clinical Studies as Topic
Genetic Therapy -- legislation & jurisprudence
Government Regulation
Neurodegenerative Diseases -- therapy
United States
United States. Food and Drug Administration

40. Refusal of inspection by a foreign food establishment or foreign government: guidance for industry

Publication:: [Silver Spring, MD] : Office of Regulatory Affairs, October 2022
Subject(s):: Federal Government
Food Inspection -- legislation & jurisprudence
Food Safety
Government Regulation
Refusal to Participate
United States
United States. Food and Drug Administration