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

Start Over Subjects Drug Approval ✖ Subjects United States ✖

61. Providing regulatory submissions in alternate electronic format

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

62. Providing regulatory submissions in electronic format: certain human pharmaceutical product applications and related submissions using the eCTD specifications

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

63. The "deemed to be a license" provision of the BPCI Act: questions and answers

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

64. Competitive generic therapies

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

65. Population pharmacokinetics

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2022
Subject(s):: Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Pharmacokinetics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

66. Pre-Launch Activities Importation Requests (PLAIR)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):: Dosage Forms -- standards
Drug Approval
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

67. Providing submissions in electronic format: postmarketing safety reports

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Drug Approval
Electronic Mail
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

68. Drug products, including biological products, that contain nanomaterials

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Biological Products -- standards
Drug Approval
Drug Development
Nanostructures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

69. Providing regulatory submissions in electronic and non-electronic format: promotional labeling and advertising materials for human prescription drugs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Advertising -- legislation & jurisprudence
Advertising -- standards
Drug Approval
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

70. Bioavailability studies submitted in NDAs or INDs: general considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Biological Availability
Clinical Trials as Topic
Drug Approval
Drug Evaluation
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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