Two Kleinfeld, Kaplan and Becker attorneys analyze major medical device guidance documents issued in the first eight months of 2018.
FDA proposes to amend its rules to require a single electronic format submission for medical device premarket filings, rather than multiple paper and ...
FDA says it wants to change its public information regulations to incorporate Freedom of Information Act changes and make the process easier for the p...
FDA awards another round of pediatric device consortia grants to provide expert support to innovators of medical devices specifically for children.
FDA releases an FDA-483 with six observations from an inspection at Sun Pharmaceuticals Halol, India, manufacturing facility.
Federal Register proposed rule: FDA proposes to repeal a regulation that requires an FDA-approved NDA or ANDA for any drug product that is sterilized ...
Federal Register notice: FDA announces a 10/10 Oncologic Drugs Advisory Committee meeting to review a Celltrion BLA for a proposed biosimilar to Genen...
Federal Register notice: FDA announces a public workshop entitled Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatme...