Simulations Plus completes an FDA-funded project for a model-integrated design for bioequivalence studies in long-acting injectable drugs.
FDA commissioner Robert Califf says the agency is considering asking Congress for additional authority to have the option of requiring drug sponsors ...
The Biotechnology Innovation Organization suggests ways for FDA to create a conceptual framework to inform decision-making for pediatric cancer drugs.
PhRMA cites FDA statistics to support its position that the Federal Trade Commission and Department of Justice dont need new ways to evaluate how drug...
FDA says Pfizer is recalling five lots of Accupril due to the presence of a nitrosamine above the acceptable daily level.
FDA says it is interested in working with Congress to find a legislative solution, most likely a bill that would be added to the user fee reauthorizat...
Federal Register notice: FDA sends to OMB an information collection revision entitled Expanded Access to Investigational Drugs for Treatment Use.
Janssen asks a New York federal court to stop several drug wholesalers from selling counterfeit versions of the companys HIV drugs.