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

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41. 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

42. 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

43. 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

44. 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

45. 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

46. 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

47. 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

48. 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

49. Multiple endpoints in clinical trials: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biostatistics
Clinical Trials as Topic
Endpoint Determination
Government Regulation
United States
United States. Food and Drug Administration

50. Laboratory accreditation for analyses of foods: what you need to know about the FDA regulation : guidance for industry : small entity compliance guide

Publication:: Rockville, MD : Center for Food Safety and Applied Nutrition, October 2022
Subject(s):: Food Analysis -- legislation & jurisprudence
Food Safety
Government Regulation
Laboratories
Legislation, Food
United States
United States. Food and Drug Administration

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