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Drugmakers seeking marketing authorization in the EU may request a meeting with the European Medicines Agency to discuss questions posed by the agency’s advisory committees, updated guidance says.
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A House subcommittee chairman wants the FDA to explain its practices relating to publication and distribution of untitled letters, after hearing complaints from companies that the agency’s policies are inconsistent and, in some cases, unfair. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
FDA approval of Pfizer subsidiary Wyeth’s Rapamune for lymphangioleiomyomatosis may be the light at the end of the tunnel for sufferers of the extremely rare lung disease. Read More
While nearly three-quarters of generic drugs saw prices fall in 2013, the 27 percent that saw price increases led to the smallest average annual decline in seven years, a new report finds. Read More
The FDA on Wednesday approved Patheon Pharmaceuticals’ Viberzi and Salix Pharmaceuticals’ Xifaxan for the treatment of irritable bowel syndrome with diarrhea in adult patients. Read More
The FDA is working on a new bioinformatic approach to evaluating the sameness of a generic drug’s active ingredient compared with that of the reference product. Read More
A federal judge dealt Otsuka a blow, dismissing claims that the FDA is precluded from approving generic versions of its blockbuster antipsychotic Abilify until its orphan exclusivity runs out in December 2021. Read More
The FDA’s Drug Safety Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committees will meet jointly in early July to discuss whether postmarket studies of reformulated OxyContin extended-release tablets show reduced misuse and abuse of the blockbuster pain reliever. Read More