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Federal Register notice: FDA makes available a draft guidance entitled Treatment for Heart Failure: Endpoints for Drug Development.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.
Human Drugs
FDA OKs Janssens Darzalex for Multiple Myeloma
FDA approves a Janssen Pharmaceutical Companies Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with n...
Biologics
Pfizer BLA for Avastin Biosimilar
FDA approves a Pfizer BLA for Zirabev (bevacizumab-bvzr), a biosimilar to Genentechs Avastin (bevacizumab).
FDA General
House Budget Bill Includes $185 Million FDA Boost
The House passes FDAs fiscal year 2020 budget as part of HR 3055, a five-bill minibus that would give the agency a $185 million (6%) increase for FY 2...
