Search results: Sage Journals

Open accessReview articleFirst published 2018

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

Michael Epstein

Therapeutic Advances in Gastroenterology

Free accessReview articleFirst published March, 2011

Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators

Carl Anderson, Patti A. Young, Ann Berenbaum

Journal of Diabetes Science and Technology

Free accessResearch articleFirst published February, 2024

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

Free accessMeeting reportFirst published March, 2012

Implications of the New Food and Drug Administration Draft Guidance on Human Factors Engineering for Diabetes Device Manufacturers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

Retricted accessOtherFirst published July, 2002

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

Free accessReview articleFirst published December, 2022

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

Retricted accessResearch articleFirst published July, 2016

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

Nobuyuki Sekine, Yasuo Ohashi, Atsushi Aruga

Therapeutic Innovation & Regulatory Science

Retricted accessLetterFirst published April, 2015

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

Dennis Dixon

Clinical Trials

Retricted accessOtherFirst published May, 2007

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

Faraneh Attarchi

Therapeutic Innovation & Regulatory Science

Available accessResearch articleFirst published August, 2008

Draft Guidance for Sponsors,Industry,Researchers,Investigators,and Food and Drug Administration Staff: Certifications to Accompany Drug,Biological Product,and Device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

Open accessReview articleFirst published 2018

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

Michael Epstein

Therapeutic Advances in Gastroenterology

Free accessReview articleFirst published March, 2011

Food and Drug Administration Guidance: Supervisory Responsibilities of Investigators

Carl Anderson, Patti A. Young, Ann Berenbaum

Journal of Diabetes Science and Technology

Free accessResearch articleFirst published February, 2024

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

Free accessMeeting reportFirst published March, 2012

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

Retricted accessOtherFirst published July, 2002

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

Free accessReview articleFirst published December, 2022

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

Retricted accessResearch articleFirst published July, 2016

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

Nobuyuki Sekine, Yasuo Ohashi, Atsushi Aruga

Therapeutic Innovation & Regulatory Science

Retricted accessLetterFirst published April, 2015

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

Dennis Dixon

Clinical Trials

Retricted accessOtherFirst published May, 2007

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

Faraneh Attarchi

Therapeutic Innovation & Regulatory Science

Available accessResearch articleFirst published August, 2008

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