Sage Journals: Discover world-class research

Retricted access

Research article

First published 2007-07

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy

Dulce Obias-Manno, Pamela E. Scott, Joseph Kaczmarczyk [...]

Journal of Women's Health

Retricted access

Research article

First published 1983-9

New Drugs and FDA Publicity

Wayne L. Pines

Annals of Pharmacotherapy

Retricted access

Research article

First published 2023-02

What Is a Drug? Enabling the Bioeconomy Through Updated Food and Drug Administration Policy

Alison L. Van Eenennaam

GEN Biotechnology

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

Retricted access

Editorial

First published 2023-01

On the Recent Changes to Animal Protection Measures in United States Food and Drug Administration Policy

Bruce J. Melancon

ASSAY and Drug Development Technologies

Retricted access

Research article

First published 2016-03

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

Merina Elahi, Noha Eshera, Nkosazana Bambata [...]

Journal of Women's Health

Retricted access

Research article

First published 2016-5

Trend Analysis of FDA Warning Letters Issued to Medical Products About Violations to Current Good Manufacturing Practices (CGMP) Between 2007 and 2014

Liqing Wang, Hang Zheng, Xiaohong Ren [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

Retricted access

Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

Free access

Research article

First published 2018-7

Anticipating Industry Arguments: The US Food and Drug Administration’s Authority to Reduce Nicotine Levels in Cigarettes

Micah L. Berman, Patricia J. Zettler, David L. Ashley

Public Health Reports®

Search results