Two Wiley Rein attorneys say government lawmakers and regulators should think long and hard before backing commercial speech restrictions.
FDA agrees to reclassify pedicle screw systems for certain uses from Class 3 to Class 2 as requested by the Orthopedic Surgical Manufacturers Associat...
Hogan Lovells attorneys discuss the significance of a new FDA draft guidance on using electronic records and signatures in clinical investigations.
FDA releases its latest batch of Warning Letters that includes Adolfo E. Kaplan and Raritan Pharmaceuticals.
FDA says that PharMEDium Services is recalling certain lots of two drugs compounded using certain Hospira products that have been recalled by that com...
Fera asks FDA to determine that it does not share 180-day exclusivity for levothyroxine injection with any other company and that no ANDA for the drug...
Federal Register notice: FDA seeks comments on an information collection extension for Annual Reporting for Custom Device Exemption OMB Control Number...
The Advanced Medical Technology Association files an amicus curiae brief urging the U.S. Supreme Court to hear the case of Ethicon v. Huskey in order ...