-
FDA Warning Letters About Misleading DTC Ads Tripled During Last Year
Most Common Offense is De-emphasizing Serious Side Effect Risks in Advertisements On September 19, 2005 Thomas Abrams, head of FDA’s Division of Drug Marketing and Communications, told food and drug regulatory lawyers attending a…
-
Pfizer Agrees to New Celebrex Safety Guidelines in Canada
Health Canada Revisions to Celebrex Label Accepted by Pfizer Canada On September 21, 2005 Pfizer Canada announced the drug company had agreed to make changes suggested by Health Canada that add new safety guidelines…
-
FDA To Hold Two-Day Direct-To-Consumer Advertising Meeting In November 2005
Public Meeting to Review Rules Concerning Prescription Drug DTC Advertisements The FDA is considering revising rules about, first, how much side-effect risk information prescription drug commercials must include and, second, whether all direct-to-consumer ("DTC")…
-
Even One Day of Vioxx Use Can Cause Heart Attack or Stroke Says Expert
Dr. Benedict Lucchesi Testifies at Humeston Vioxx Trial in New Jersey Dr. Benedict Lucchesi, a prominent heart and medication expert from the University of Michigan, told the jury hearing evidence at the Humeston Vioxx…
-
Federal Authorities Investigating Suspected Fraud in Fen-phen Class Action Settlement
Some Claimants’ Lawyers May Have Submitted Bogus Heart-damage Claims The U.S. Attorney’s Office in Philadelphia and the FBI are investigating allegations of fraud in the $5 billion fen-phen class action settlement. The federal investigators…
-
Two Key FDA Officials Tell IOM Panel About Their Concerns Over Current Drug-safety System
Lack Of Authority for FDA to Evaluate Safety of Drugs After Marketing Approval On June 8, 2005 Steven K. Galson, acting director of FDA’s Center for Drug Evaluation and Research (CDER), and Janet Woodcock,…
