Three Ropes & Gray attorneys analyze three FDA draft guidances intended to modernize the 510(k) program, saying they are likely to be precursors to fu...
Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and W...
FDA says it is converting its medical device Accreditation Scheme for Conformity Assessment from a pilot to a permanent program.
A federal judge sentences Byron A. Marshall of Houston, TX to 300 months in federal prison for his role in leading a counterfeit drug trafficking sche...
Federal Register notice: FDA makes available a draft guidance entitled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and W...
Federal Register notice: FDA seeks comments on an information collection revision entitled Electronic Records; Electronic Signatures 21 CFR Part 11. ...
Federal Register notice: FDA seeks comments on an information collection extension entitled Application for Participation in FDA Fellowship and Traine...
Vanda Pharmaceuticals calls on FDA commissioner Robert Califf to throw out a second CDER proposed order on the companys sNDA for an expanded Hetlioz i...
