CDER embraces industrys use of physiologically based pharmacokinetic modeling as an alternative bioequivalence (BE) approach after approving a Perrigo...
Pharmaceutical Research and Manufacturers of America tells FDA its draft guidance on reporting the amount of listed drugs and biological products woul...
The Council for Responsible Nutrition says FDA failed to respond to its legal inquiry on the agencys policy shift involving marketing dietary suppleme...
The Justice Department says a federal grand jury indictment charges a North Carolina doctor with multiple offenses related to Medicare billing for bal...
FDA clears the VySpine VySpan posterior cervical thoracic system.
PhRMA and Lilly say a proposed FDA study on proprietary names is not likely to provide useful information.
FDA cleares a Biolase 510(k) for the EdgePro system for cleaning and disinfection during root canal procedures performed by endodontists.
FDA approves an Otsuka America Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in pediatric pat...