Human Drugs
FDA Rejects Merck NDA for Chronic Cough
FDA issues Merck a complete response letter on its NDA for gefapixant, an orally administered selective P2X3 receptor antagonist for treating refracto...
Human Drugs
FDA Hits Viking Therapeutics with Clinical Hold
FDA places a clinical hold on a Viking Therapeutics Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy.
Medical Devices
Medtronic Neurostimulators OKd for Diabetic Neuropathy
FDA approves a Medtronic PMA for its Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator for treating chronic pain associate...
Human Drugs
Ex-Clinical Study Manager Sentenced to 30 Months
A Florida federal court sentences former clinical study coordinator Duniel Tejeda to 30 months in prison for his participation in a conspiracy to fals...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 1/21/2022.
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 1/21/2022.
Federal Register
FDA Seeks Comments on Covid Guidances
Federal Register notice: FDA announces recent guidance documents related to the Covid-19 public health emergency.
Federal Register
Draft Guide on 702(b) FDA Samples
Federal Register notice: FDA makes available a draft guidance entitled Collecting and Providing 702(b) Portions of FDA Official Samples Questions and...
Federal Register
FDA Revokes 5 Covid Test EUAs
Federal Register notice: FDA revokes the Emergency Use Authorizations for five Covid tests because they are no longer marketed, distributed or support...
