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Recommendations in the latest installment of the Prescription Drug User Fee Act (PDUFA) seek to bulk up the premarket drug approval process, stabilize financing and expedite drug development, FDA officials said at a public hearing last week.
The FTC will continue to pursue an anticompetitive case against Barr Laboratories following a federal district court ruling rejecting the generic firm's motion to dismiss the case, agency sources said.
Members of the Senate Judiciary Committee unanimously approved Sen. Herb Kohl's (D-Wis.) reverse-payment legislation -- bringing the prohibition of that practice a step closer to becoming law.
Sanofi-aventis has filed a patent infringement lawsuit in federal court to block the manufacturing and marketing of zolpidem tartrate, a generic version of its blockbuster sleep drug Ambien CR.
The FDA is exempting drugs that will be used for the President's Emergency Plan for AIDS Relief (PEPFAR) from Prescription Drug User Fee Act fees to lessen the financial difficulties associated with developing the products, an agency guidance says.
The reintroduced "Access to Life-Saving Medicine Act," a bill that would establish a clear and effective pathway for the FDA to approve generic copies of biologic drugs, may be attached to the Prescription Drug User Fee Act (PDUFA), congressional lawmakers said this week.
Public Citizen has filed a petition asking the FDA to ban third-generation oral contraceptives containing desogestrel, saying the pills double the risk of blood clots compared with pills without the ingredient while not having any clinical benefit over older medications.
While recent Centers for Disease Control and Prevention (CDC) data show an increase in the number of adolescent suicides since black box warnings were added to some types of antidepressants, there may not be enough data to link the two, a government source says.
A forceful "culture of approval" and attempts to muffle scientific dissent among agency reviewers have created significant problems in the FDA's drug review process, witnesses at a House subcommittee hearing testified.