Medical Devices
Baxter De Novo Granted for Theranova Dialysis Membrane
FDA grants Baxter International a de novo application for the Theranova dialysis membrane.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Panel Meeting on Alkermes Schizophrenia/Bipolar Drug
Federal Register notice: FDA announces a 10/9 Advisory Committee meeting to review Alkermes NDA for schizophrenia and bipolar disorder drug applicatio...
Medical Devices
Guide on Device Patient-Reported Outcome Instruments
FDA issues a draft guidance on patient-reported outcome instruments for use in medical device evaluations.
Federal Register
Non-specific Covid-19 Panel Meeting 10/22
Federal Register notice: FDA announces a 10/22 Vaccines and Related Biological Products Advisory Committee meeting.
Human Drugs
More ANDA Product-Specific Guidances
FDA publishes new product-specific guidances that provide recommendations for developing generic drugs and generating data needed to support ANDA appr...
Human Drugs
Hahn Removes New Press Head After Controversial Remarks
FDA commissioner Stephen Hahn fires newly appointed chief spokeswoman Emily Miller in the wake of his controversial remarks exaggerating the efficacy ...
Medical Devices
Synchron Breakthrough Status for Paralysis Brain Device
FDA grants Synchron a breakthrough device designation for Stentrode, an implantable medical device that can translate brain activity from inside a blo...
Medical Devices
FDA Safety Alert on Laws PPE of Motion Gowns
FDA alerts healthcare facilities to stop using medical gowns, including surgical gowns, manufactured or sold by New York City-based Laws of Motion PPE...
Federal Register
Draft Guide on CNS Cancer Drugs
Federal Register notice: FDA makes available a draft guidance entitled Evaluating Cancer Drugs in Patients with Central Nervous System Metastases.
