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The Bush administration’s nomination of Andrew von Eschenbach to be the FDA commissioner faces an uncertain future that has less to do with the new Democratic Senate leadership than it does with members of the president’s own party.
Now that the Democrats will control the House of Representatives for the first time since 1994, legislation and oversight will be in the hands of some very vocal critics of HHS policy regarding drug safety and effectiveness, FDA oversight and drug prices, particularly in Medicare.
Spectrum Pharmaceuticals will begin distributing the authorized generic version of GlaxoSmithKline’s (GSK) Imitrex Injection by November 2008 under a proposed patent settlement.
The FDA, European regulators and industry are struggling to agree on a standard for the amount of data sufficient for sponsors to submit drug applications — a key obstacle to widespread use of adaptive trial designs, sources say.
In its first major announcement since the midterm elections gave control of the next Congress to the Democrats, the FDA outlined what it believes should be the priorities to improve drug safety without sacrificing innovation.
Merck has responded to the FDA’s approvable letter for its new arthritis pain reliever Arcoxia with new study data and now expects a decision in April 2007.
With the Democrats taking control of the Senate, the healthcare agenda will likely focus on increasing the availability of generics in the market, improved drug safety and the role of trade policy in protecting domestic pharmaceuticals, according to industry observers.
Bausch & Lomb’s MoistureLoc contact lens solution was cited as “adulterated” in a recent FDA warning letter, which followed an agency inspection that found the firm did not conform to good manufacturing practice requirements.
The investigator in two clinical trials of the same device told the FDA he did not know how to access study data and did not know which patients were enrolled, according to a recent warning letter.