Human Drugs
FDA and UK Expand Mutual Recognition Agreement
FDA and the United Kingdom expand their ongoing mutual recognition agreement to include animal drug inspections.
Medical Devices
Alert on Left Atrial Appendage Occlusion Devices
FDA alerts health care providers on recent information about the potential for differences in procedural outcomes between women and men undergoing imp...
Human Drugs
CDER Head Talks Quality Management Maturity
CDER director Patrizia Cavazzoni tells an industry conference that agency inspectors are emphasizing the importance of having in place effective risk-...
Medical Devices
Enforcement Discretion for Certain IVD Studies
FDA says it intends to exercise enforcement discretion regarding a requirement for informed consent for in vitro diagnostic device studies using lefto...
Human Drugs
Clinical Hold Lifted on Angelman Syndrome Study
FDA removes a clinical hold against a GeneTx Biotherapeutics and Ultragenyx Pharmaceutical clinical trial of GTX-102, an investigational treatment for...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 9/24/2021.
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 for the week ending 9/24/2021.
Human Drugs
FDA Extends Review of Pfizer Growth Hormone
FDA extends by three months the review of a Pfizer/Opko Health BLA for somatrogon, a once-weekly long-acting recombinant human growth hormone for trea...
Medical Devices
Armstrong Medical Recalls Anesthesia Gas Cans
Armstrong Medical recalls its Amsorb Plus Prefilled G-Can 1.0L due to reports that some canisters have difficulties with gas flow that may cause a red...
