Search results: Sage Journals

Retricted accessOtherFirst published April, 2002

The United States Food and Drug Administration's Risk Management Framework

Gina Steidle, Shawn E. Hodges

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published March, 1997

The United States Food and Drug Administration Paradigm for the Regulation of Tissue-Engineered Products

Thomas L. Eggerman, Amy P. Patterson

Tissue Engineering Part A: Research Advances

Retricted accessResearch articleFirst published July, 1997

An Index of United States Federal Regulations and Guidelines Which Cover Clinical Safety Surveillance of Biological Products

Charles F. Curran, Judith M. Sills

Therapeutic Innovation & Regulatory Science

Retricted accessOtherFirst published April, 1999

The Evolving Paradigm for Clinical Development and Regulatory Approval of Antiretroviral Drugs in the United States

David M. Cocchetto, Lynn Smiley

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published July, 2016

Unsafe Drugs Were Prescribed More Than One Hundred Million Times in the United States Before Being Recalled

Sonali Saluja, Steffie Woolhandler, David U. Himmelstein [...]

International Journal of Social Determinants of Health and Health Services

Retricted accessResearch articleFirst published April, 2022

Adverse Events Related to Cartiva Hemiarthroplasty of First Metatarsal: An Analysis of Reports to the United States Food and Drug Administration

Sreenivasulu Metikala, Karim Mahmoud, Kathryn M. O’Connor [...]

Foot & Ankle Specialist

Retricted accessResearch articleFirst published January, 1995

The Regulation of Acupuncture Needles by The United States Food and Drug Administration

James S. Turner

Journal of Integrative and Complementary Medicine

Free accessEditorialFirst published February, 2011

The United States Food and Drugs Administration Approves a Generic Enoxaparin

Frederick A. Ofosu

Clinical and Applied Thrombosis/Hemostasis

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

Available accessResearch articleFirst published September, 2016

Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration

Matthew Oram

History of Psychiatry: Madness,Science,Culture

Retricted accessOtherFirst published April, 2002

The United States Food and Drug Administration's Risk Management Framework

Gina Steidle, Shawn E. Hodges

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published March, 1997

The United States Food and Drug Administration Paradigm for the Regulation of Tissue-Engineered Products

Thomas L. Eggerman, Amy P. Patterson

Tissue Engineering Part A: Research Advances

Retricted accessResearch articleFirst published July, 1997

An Index of United States Federal Regulations and Guidelines Which Cover Clinical Safety Surveillance of Biological Products

Charles F. Curran, Judith M. Sills

Therapeutic Innovation & Regulatory Science

Retricted accessOtherFirst published April, 1999

The Evolving Paradigm for Clinical Development and Regulatory Approval of Antiretroviral Drugs in the United States

David M. Cocchetto, Lynn Smiley

Therapeutic Innovation & Regulatory Science

Retricted accessResearch articleFirst published July, 2016

Unsafe Drugs Were Prescribed More Than One Hundred Million Times in the United States Before Being Recalled

Sonali Saluja, Steffie Woolhandler, David U. Himmelstein [...]

International Journal of Social Determinants of Health and Health Services

Retricted accessResearch articleFirst published April, 2022

Adverse Events Related to Cartiva Hemiarthroplasty of First Metatarsal: An Analysis of Reports to the United States Food and Drug Administration

Sreenivasulu Metikala, Karim Mahmoud, Kathryn M. O’Connor [...]

Foot & Ankle Specialist

Retricted accessResearch articleFirst published January, 1995

The Regulation of Acupuncture Needles by The United States Food and Drug Administration

James S. Turner

Journal of Integrative and Complementary Medicine

Free accessEditorialFirst published February, 2011

The United States Food and Drugs Administration Approves a Generic Enoxaparin

Frederick A. Ofosu

Clinical and Applied Thrombosis/Hemostasis

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

Available accessResearch articleFirst published September, 2016

Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration

Matthew Oram

History of Psychiatry: Madness,Science,Culture