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Articles (220)

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1-10 of 220 results for Food and Drug Administration guidance

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Select article: Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist

Open access

Review article

First published 2018

Food and Drug Administration guidances on biosimilars: an update for the gastroenterologist

Michael Epstein

Therapeutic Advances in Gastroenterology

Select article: Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators

Free access

Review article

First published 2011-3

Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators

Carl Anderson, Patti A. Young, Ann Berenbaum

Journal of Diabetes Science and Technology

Select article: Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies

Free access

Research article

First published 2024-2

Scientific and Regulatory Policy Committee Points to Consider: Review of the United States Food and Drug Administration (FDA) Guidance on Pathology Peer Review in Nonclinical Toxicology Studies

Kevin S. McDorman, Bindu M. Bennet, Karyn Colman [...]

Toxicologic Pathology

Select article: Implications of the New Food and Drug Administration Draft Guidance on Human Factors Engineering for Diabetes Device Manufacturers

Free access

Meeting report

First published 2012-3

Implications of the New Food and Drug Administration Draft Guidance on Human Factors Engineering for Diabetes Device Manufacturers

Stephen B. Wilcox, Daniel Drucker

Journal of Diabetes Science and Technology

Select article: Recommendations to the Food and Drug Administration: Metered Dose Inhaler Tests and Methods in the Chemistry,Manufacturing,and Controls Draft Guidances for Metered Dose Inhalers and Dry Powder Inhalers

Retricted access

Other

First published 2002-7

Recommendations to the Food and Drug Administration: Metered Dose Inhaler Tests and Methods in the Chemistry,Manufacturing,and Controls Draft Guidances for Metered Dose Inhalers and Dry Powder Inhalers

Lee M. Nagao

Therapeutic Innovation & Regulatory Science

Select article: Food and Drug Administration Guidance on Design of Clinical Trials for Gene Therapy Products with Potential for Genome Integration or Genome Editing and Associated Long-Term Follow-Up of Research Subjects

Free access

Review article

First published 2022-12

Food and Drug Administration Guidance on Design of Clinical Trials for Gene Therapy Products with Potential for Genome Integration or Genome Editing and Associated Long-Term Follow-Up of Research Subjects

Daniel Eisenman, Scott Swindle

Applied Biosafety

Select article: Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals

Retricted access

Research article

First published 2016-7

Applicability of Selective Data Collection to Cancer Clinical Studies for Supplemental Marketing Approvals

Nobuyuki Sekine, Yasuo Ohashi, Atsushi Aruga

Therapeutic Innovation & Regulatory Science

Select article: Food and Drug Administration guidance on progression-free survival and the intention-to-treat principle

Retricted access

Letter

First published 2015-4

Food and Drug Administration guidance on progression-free survival and the intention-to-treat principle

Dennis Dixon

Clinical Trials

Select article: Exploratory IND Studies: A Review of Food and Drug Administration Guidance and Similar Provision in Europe

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Other

First published 2007-5

Exploratory IND Studies: A Review of Food and Drug Administration Guidance and Similar Provision in Europe

Faraneh Attarchi

Therapeutic Innovation & Regulatory Science

Select article: Draft Guidance for Sponsors,Industry,Researchers,Investigators,and Food and Drug Administration Staff: Certifications to Accompany Drug,Biological Product,and Device Applications/Submissions

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Research article

First published 2008-08

Draft Guidance for Sponsors,Industry,Researchers,Investigators,and Food and Drug Administration Staff: Certifications to Accompany Drug,Biological Product,and Device Applications/Submissions

Biotechnology Law Report

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