Subjects: Drug Approval - Digital Collections - National Library of Medicine Search Results

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51. Providing regulatory submissions in electronic format: content of the risk evaluation and mitigation strategies document using structured product labeling

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Drug Approval
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

52. Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Facility Regulation and Control
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

53. COVID-19: federal efforts accelerate vaccine and therapeutic development, but more transparency needed on emergency use authorizations : report to Congressional addressees

Publication:: Washington, DC : United States Government Accountability Office, November 2020
Subject(s):: COVID-19 Vaccines
Drug Approval
Drug Development
Disclosure
United States
United States. Department of Defense
United States. Department of Health and Human Services

54. Referencing approved drug products in ANDA submissions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Drug Approval
Drug Evaluation
Drug Labeling
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

55. FDA oversight

Author(s):: White, Robert S, author
Publication:: [Toronto, Ontario] : Thomson Reuters, 20-December-2021
Subject(s):: Drug Approval
Drug Therapy
Drugs, Investigational
Government Regulation
Illicit Drugs
United States
United States. Food and Drug Administration.

56. Chemistry, manufacturing, and controls changes to an approved application: certain biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Biological Products
Drug Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

57. Providing regulatory submissions in electronic format: standardized study data

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Data Management
Drug Approval
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

58. ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Chemistry Techniques, Synthetic
DNA, Ribosomal
Drug Approval
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

59. Principles of premarket pathways for combination products: guidance for industry and FDA Staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2022
Subject(s):: Biological Products
Device Approval
Drug Approval
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

60. Development of abbreviated new drug applications during the COVID-19 pandemic: questions and answers

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, September 8, 2021
Subject(s):: COVID-19
Drug Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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