The FDA has said enough is enough to McNeil Consumer Healthcare over its repeated manufacturing problems, issuing a consent decree Thursday that indefinitely closes one plant and places oversight over two others.
The House Energy & Commerce Committee voted 46-0 Thursday to approve its version of an FDA user fee bill, keeping on track to have the bill signed into law by the end of June.
The FTC may not issue the advisory opinion GPhA is waiting for before launching its third-party drug shortage program, possibly derailing the initiative.
Drugmakers should view Thursday’s landmark Supreme Court ruling on the 2010 Affordable Care Act (ACA) as an overall victory, industry analysts and consultants say.
JERSEY CITY, N.J. — Due to increasing pressures from Congress, the NIH is moving away from funding basic medical research and shifting toward translational work, a field once reserved for the pharmaceutical industry.
Ideas to Alleviate Drug Shortages Are Plenty at GDUFA Hearing, Which Ones Will Stick Remains to Be Seen
Most who are following the user fee bills pending in Congress expect lawmakers to combine the Generic Drug User Fee Act (GDUFA) with legislation to address the escalating problem of drug shortages. The two go together since most drugs on the FDA’s current shortages list are generic injectables.
A federal judge harshly questioned Mylan’s standing to sue the FDA in efforts to wedge itself into the 180-day exclusivity period for a generic version of the blockbuster drug Lipitor.
Some Democratic lawmakers are pushing for a drug pedigree system to combat potential “gray marketing” of shortage drugs, arguing that a national track-and-trace system would not be enough to secure the supply chain.