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Regulatory Articles
FDA to Merck: Wait until 2013 for cholesterol drug
Stephen McGuire
June 23, 2008
Merck may have to wait until 2013 before the FDA reconsiders approval of its cholesterol drug known as Cordaptive (MK-0524A).
AMA CME measure goes nowhere
Matthew Arnold
June 16, 2008
A proposal by the American Medical Association's Council on Ethical and Judicial Affairs (CEJA) calling for the elimination of commercial sponsorship of medical education was referred back to the council, effectively tabling it for the year.
Grassley: researchers misreported commercial pharma payments
Ben Comer
June 09, 2008
Harvard researchers failed to report pharmaceutical company incomes, a possible violation of university rules and federal law. The story was first reported on Sunday, in the New York Times.
GSK blood drug works same as placebo: FDA
Stephen McGuire
May 28, 2008
GlaxoSmithKline's (GSK) experimental drug Promacta (eltrombopag) failed to significantly lower bleeding in patients with the rare blood disorder it was designed to treat, the FDA said.
Merck agrees to pre-approval of TV ads in Vioxx settlement
Matthew Arnold
May 22, 2008
Merck has agreed to submit all TV ads to the FDA before running them and to adhere to agency recommendations on them as part of a Vioxx-related settlement.
New York governor wants gift ban
Matthew Arnold
May 22, 2008
New York Gov. David Paterson is proposing legislation that would impose a ban on gifts to doctors and require physicians making presentations at CME events to disclose any financial relationships with drug companies.
Senate Sunshine law gets update, Lilly endorsement
Matthew Arnold
May 14, 2008
Sens. Grassley (R-IA) and Kohl (D-WI) released a somewhat softer version of their Physician Payments Sunshine Act while praising Eli Lilly & Co. for endorsing the legislation.
Pfizer joins transparency push, posts grants online
Matthew Arnold
May 14, 2008
Pfizer followed Eli Lilly's lead in posting a list of $10 million in grants and charitable contributions the company made to US medical, scientific and patient organizations during the first quarter of 2008 as "part of an ongoing drive throughout the company to increase transparency."
Gardasil sBLA given priority review
Stephen McGuire
March 19, 2008
Merck said today that the FDA has granted priority review status to the company's supplemental Biologics License Application (sBLA) for Gardasil (human papillomavirus quadrivalent) for use in women aged 27 through 45.
Woodcock to return to CDER director post
Stephen McGuire
March 11, 2008
FDA deputy commissioner Janet Woodcock will return to the role of permanent director of the Center for Drug Evaluation and Research following a "national search" to fill the slot.
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