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Due to concerns over its methodology and timeliness, both industry officials and patient advocates are questioning how much influence a recent study of implantable cardioverter defibrillators (ICDs) should have in setting FDA policy.
A U.S. federal district court will begin hearing a dispute Sept. 26 that could set a national precedent for what device manufacturers must do to meet the FDA’s current good manufacturing practices.
Physicians and patient advocates are calling on the FDA to make fundamental changes to how the agency addresses medical device malfunctions — specifically by better defining product recalls, by clarifying when physicians should be alerted to device problems, and by concentrating more resources on monitoring the manufacture of particularly “high-risk” products such as implantable cardioverter-defibrillators (ICDs).
Retail prices for frequently used brand drugs have increased roughly three times faster than those of commonly used generic drugs, according to a Government Accountability Office (GAO) report.
Sanofi-aventis and its development partner have a filed a motion for preliminary injunction in federal court to block generic sales of the highly profitable allergy drug Allegra.
Drugmakers should craft their pharmaceutical promotions in a way that gives equal weight to a product’s risks and claims, suggests the head of the FDA’s advertising oversight division, which has ratcheted up its scrutiny of the product promotions in recent months.
Pfizer has received an FDA “non-approvable” letter for parecoxib, a non-narcotic injectable Cox-2 inhibitor already approved and marketed in the European Union (EU).
The FDA’s current policy on follow-on biologics amounts to a “monopoly” situation for brand firms, according to two prominent lawmakers who helped shape the current generic drug industry.