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Boston Scientific on July 2 recalled 200 units of its drug-eluting Taxus Express2 stent due to a catheter balloon deflation problem that caused one patient death and serious injuries to 16 others.
Concerned that a department charged with protecting the public interest appears to be a “lapdog” with little independence, a key Republican lawmaker is urging the General Accounting Office (GAO) to conduct a broad review of the FDA’s drug safety arm.
Endo Pharmaceuticals has reached an agreement with the FDA on the design of a new clinical trial to confirm the safety and efficacy of its experimental pain drug, oxymorphone extended-release (ER) tablets, the firm said last week.
Even though most attention is fixed on the billion-dollar generic patent drug battles, the FDA has been quietly approving scores of generic applications targeting products for which patents are not being contested.
A member of Congress has warned that a pending trade agreement with Australia could block the importation of prescription drugs from Australia into the U.S. and set a precedent for blocking drug importation from other countries as part of future free trade agreements (FTAs).
Amid growing controversy about the suppression of negative trial results, PhRMA announced it has adopted new voluntary principles to encourage drugmakers to release comprehensive data about clinical trials.
The FDA denied citizen petitions submitted by two prominent generic drugmakers seeking to prohibit the marketing of authorized generic drugs during another generic firm’s 180-day exclusivity period.
A federal court in the District of Columbia has refused King Pharmaceuticals’ request to revoke FDA approval of supplemental new drug applications (sNDAs) that propose to establish bioequivalence between King’s thyroid product Levoxyl and two other products: Jerome Stevens’ Unithroid and Mova Pharmaceutical’s Levo-T.
A Missouri-based contract laboratory recently found itself on the receiving end of an FDA warning letter following an inspection that revealed a slew of cGMP deficiencies, including uncorrected violations discovered during inspections in 2000 and 2001.