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FDA advisory committee members overwhelmingly recommended approval of Indivior’s RBP-6000, an extended-release reformulation of buprenorphine for the treatment of opioid abuse. Read More
The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More
Two Endo International subsidiaries sued the FDA last week to have the agency’s bulk drug compounding decree on compounding operations declared illegal and to halt compounding involving the API vasopressin. Read More
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in previously untreated patients. Read More
The European Medicines Agency published a new draft guideline on developing medicines and vaccines against respiratory syncytial virus infections, including monoclonal antibodies and direct-acting antivirals. Read More
The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement. Read More
The FDA is looking for creative approaches to the opioid crisis, including new requirements for product packaging, as ways to reduce overall exposure to the painkillers. Read More