Data from the US Military Health System related to the review and use of FDA-regulated drugs, biologics and medical devices will be shared with the FDA to help safety reviews.
Jazz Pharmaceuticals will pay $20 million in penalties and victim compensation to resolve criminal and civil investigations into illegal marketing by its Orphan Medical wholly owned subsidiary.
Demand is increasing for former FDA commissioner Lester Crawfords services now that his ethics conviction for failing to appropriately report and manage his stock holdings is behind him.
FDA orders clinical hold on Targeted Genetics trial
The FDA has ordered a clinical hold on a Targeted Genetics clinical trial involving tgAAC94, an investigational therapy indicated for treating inflammatory arthritis.
Baucus and Grassley say the FDA suppresses scientific dissent
Sens. Max Baucus (D-MT) and Chuck Grassley (R-IA) say the FDA continues to suppress scientific dissent and punish agency staff who raise safety issues.
A nonprofit patient advocacy group has filed suit against the FDA in an Ohio federal court seeking to overturn the agencys decision earlier this year to not approve Dendreons prostate cancer vaccine Provenge.
While some attorneys and other observers say that drug companies often use citizen petitions as a means to delay the FDA approval of a generic drug after a branded companys patent has expired, Pharmaceutical Research and Manufacturers of America (PhRMA) says there is only scant evidence that they are filed purely to block generics.
The House Judiciary Committee voted before the summer congressional recess to approve and send to the House a bill observers said would overhaul the US patent system by weeding out bad patents and restraining excessive litigation over patents.
FDA associate commissioner for regulatory affairs Margaret OK. Glavin should be removed from her post for sending a retaliatory all-hands memo to the agencys field employees shortly after congressional testimony by several dissident field managers gave the agency low grades for its food inspection performance, House Energy and Commerce leaders said in a letter to FDA commissioner Andrew von Eschenbach.