Medical Devices
Warren, Murray Question CDRH Progressive Approval
Sens. Warren and Murray ask FDA to answer questions about the CDRH progressive approval of medical devices program, which they say was denied by forme...
Medical Devices
2 CDRH Appeals Process Guidances
FDA issues two guidance on CDRH appeals processes for outside stakeholders.
Federal Register
Patient Engagement Panel to Review Device Cybersecurity
Federal Register notice: FDA announces a 9/10 Patient Engagement Advisory Committee meeting to discuss and make recommendations on Cybersecurity in Me...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 7/5/2019.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 7/5/2019.
Human Drugs
Guide on Epidermolysis Bullosa Drug Development
FDA posts a final guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.
Federal Register
Workshop on Heart Failure Drug Endpoints
Federal Register notice: FDA announces a 7/26 public workshop entitled Endpoints for Drug Development in Heart Failure.
Federal Register
Draft Guide on Heart Failure Drug Endpoints
Federal Register notice: FDA makes available a draft guidance entitled Treatment for Heart Failure: Endpoints for Drug Development.
Federal Register
Proposed Rule on Biologic Master Files
Federal Register proposed rule: FDA proposes to amend its regulations concerning the use of master files for biological products.
