The FDA has introduced a new designation for regenerative medicine therapies, laying out the submission requirements for sponsors seeking the expedited review that stems from the 21st Century Cures Act.…
The European Medicines Agency recommended 81 drugs for approval in 2016, down from 93 the year before. Source: Drug Industry Daily
The FDA compiled 22 case studies of different drugs, vaccines and devices that demonstrated promising results in Phase II studies, but later failed in larger Phase III clinical trials. Source:…
The high court will review Bristol-Myers Squibb’s appeal of a California Supreme Court ruling that grants the state’s courts jurisdiction to hear lawsuits filed by non-state residents. Source: Drug Industry…
McKesson has agreed to pay a record civil penalty of $150 million to settle DEA and Justice Department allegations that the drug distributor failed to report suspicious orders of opioids.…
Mallinckrodt will pay $100 million to settle FTC charges that the company maintained a U.S. monopoly for the only approved adrenocorticotropic hormone (ACTH) drug, Acthar, by acquiring the rights to…
The First Amendment does not preclude drugmakers from FDA’s oversight of off-label communication even if what they say is truthful. Source: Drug Industry Daily
CBER released a set of guidance topics that the center is considering for development this year, covering blood and blood components, tissues and advanced therapies, and chemistry, manufacturing and controls…
Drug manufacturer Warner Chilcott was handed a Form 483 after an inspection revealed inadequate written procedures and deficient cleaning and maintenance of equipment. Source: Drug Industry Daily