Loading ...
The FDA 
Lost in Transmission — FDA Drug Information That Never Reaches Clinicians(0)
Lisa M. Schwartz, M.D., and Steven Woloshin, M.D.
The 2009 federal stimulus package included $1.1 billion to support comparative-effectiveness research about medical treatments.
Balancing Innovation, Access, and Profits — Market Exclusivity for Biologics
Alfred B. Engelberg, J.D., Aaron S. Kesselheim, M.D., J.D., M.P.H., and Jerry Avorn, M.D.
Twenty-five years ago, Congress enacted the Waxman–Hatch Act to facilitate the approval by the Food and Drug Administration (FDA) of low-cost generic drugs that are bioequivalent to approved brand-name drugs. This law has been largely successful, in that generic drugs now account [...]
American Roulette — Contaminated Dietary Supplements
Pieter A. Cohen, M.D.
View the webcast of Body Building Products and Hidden Steroids: Enforcement Barriers, a hearing held on September 29, 2009 by the U.S. Senate Committee on the Judiciary’s Subcommittee on Crime and Drugs.
In one of the most dangerous cities in the United States, one portly police sergeant has more to [...]
New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling
Randall S. Stafford, M.D., Ph.D., Todd H. Wagner, Ph.D., and Philip W. Lavori, Ph.D.
New technologies, including prescription drugs and medical devices, are a major driver of increases in U.S. health care expenditures, which have grown by an estimated 71% since 2000.1 The U.S. market for drugs and devices is regulated by the Food and Drug [...]