Human Drugs
Fagron Recalls Lets Gel Convenience Packs
Fagron recalls its Lets Gel Kit Convenience Packs due to potential microbial contamination of non-sterile products.
Medical Devices
Philips Recalls Forte Gamma Camera System
Philips Medical Systems recalls (Class 1) the Forte Gamma Camera System due to a nonconforming material/component.
Human Drugs
RedHill Bio Gains H. Pylori Approval
FDA approves a RedHill Biopharma NDA for Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules for treating Helicobacter ...
Medical Devices
DiFusion Spinal Interbody Device Cleared
FDA clears a DiFusion 510(k) for the Xiphos-ZF Spinal interbody device.
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notice for the week ending 8/1/2019.
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 11/1/2019.
Federal Register
Hep D Virus Drug Development Guide
Federal Register notice: FDA makes available a draft guidance entitled Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.
Federal Register
Draft Guide on Generic Drug User Fees
Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees under the Generic Drug User Fee Amendments of 2017.
FDA General
Trump Taps MD Andersons Hahn as FDA Head
President Donald Trump chooses to nominate MD Anderson chief medical officer Stephen Hahn to be FDA commissioner.
