Alimta

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... FDA Accused of Dropping the Ball on Post-Marketing Studies of Fast Track Drugs - CME Teaching Brief - MedPage Today HOME/LATEST HEADLINES CONFERENCE COVERAGENEWS BY SPECIALTY Allergies & Immunology Cardiology Dermatology Endocrinology Gastroenterology Hematology/Oncology Infectious Disease/HIV Nephrology Neurology OB/GYN Ophthalmology Pediatrics Primary Care Product Alert Psychiatry Public Health & Policy Bioterrorism Genetics Medicaid & Medicare Practice Management Stem Cell Research Pulmonary Rheumatology Urology NEW USERS: REGISTER HERERETURNING USERS: LOG IN UPDATE YOUR PROFILE CME TRACKER ABOUT MEDPAGE TODAY HELP CENTER LOCAL WEATHER: FDA Accused of Dropping the Ball on Post-Marketing Studies of Fast Track Drugs By Peggy Peck, Senior Editor, MedPage Today June 01, 2005 Also covered by: Baltimore Sun (Registration Req.), MSNBC, LA Times (Registration Req.) WASHINGTON, June 1-Pharmaceutical companies have completed only 42 of the 91 post-marketing studies required under the FDA's accelerated approval process, according to a report issued today by Rep.

Edward J.

Markey (D-Mass).

The incomplete studies include those for Celebrex (celecoxib), Gleevec (imatinib), and Iressa (gefitinib), said the report.

When the FDA grants accelerated approval it does so only on the condition that the drug maker agrees to conduct further studies to confirm safety and efficacy, a condition that Rep.

Markey says both the FDA and drug...