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To curb abuse of the Hatch-Waxman system, the FDA should consider allowing generic drug manufacturers to create their own REMS, according to CVS Health. Read More
Sen. Claire McCaskill (D-Mo.) introduced legislation that would bar patent arrangements like the controversial deal between Allergan and a Native American tribe. Read More
The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described as unfair, ambiguous and impractical. Read More
The FDA is streamlining its communications with generics manufacturers, and outlined its procedures for relaying the status of an ANDA review in a new manual for staff. Read More
The trade association of the British drug industry dropped its legal challenge to new guidelines from national regulators that subject higher-priced drugs to an extra review under England’s single-payer National Health Service. Read More
The FDA strongly supports transitioning the opioid painkiller market toward abuse-deterrent formulations, Commissioner Scott Gottlieb told a Senate committee examining the abuse epidemic. Read More