Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals

Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

(2014) Nicholas S. Downing et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation

(2013) Rachel E. Sherman et al.   NEW ENGLAND JOURNAL OF MEDICINE

Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs Approved by the US Food and Drug Administration

(2013) Thomas J. Moore et al.   JAMA Internal Medicine

The Safety Risks of Innovation

(2012) Thomas J. Moore et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

User Fees and Beyond — The FDA Safety and Innovation Act of 2012

(2012) Daniel B. Kramer et al.   NEW ENGLAND JOURNAL OF MEDICINE

Principles of Conservative Prescribing

(2011) Gordon D. Schiff   ARCHIVES OF INTERNAL MEDICINE

How Many “Me-Too” Drugs Is Too Many?

(2011) Joshua J. Gagne   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Different Black Box Warning Labeling for Same-Class Drugs

(2011) Orestis A. Panagiotou et al.   JOURNAL OF GENERAL INTERNAL MEDICINE

Market withdrawal of new molecular entities approved in the United States from 1980 to 2009

(2011) Zaina P. Qureshi et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Drug-Review Deadlines and Safety Problems

(2008) Daniel Carpenter et al.   NEW ENGLAND JOURNAL OF MEDICINE

The risk we bear: The effects of review speed and industry user fees on new drug safety

(2007) Mary K. Olson   JOURNAL OF HEALTH ECONOMICS