Human Drugs
OGD Approved 100 Competitive ANDAs in 2021
CDERs Office of Generic Drugs says it approved 100-designated Competitive Generic Therapy ANDAs in 2021 for products recognized as lacking generic com...
Human Drugs
ProQR Trial in Eye Disease Fails
A pivotal Phase 2-3 trial (Illuminate) evaluating ProQR Therapeutics sepofarsen for treating genetic eye disease CEP290-mediated Leber congenital amau...
Medical Devices
Prostate Cancer Blood Test Gets Breakthrough Status
FDA grants Datar Cancer Genetics a breakthrough device designation for its TriNetra-Prostate blood test to detect early-stage prostate cancer.
Medical Devices
Motus GI Gets New Colonoscopy Device Cleared
FDA clears a Motus GI Holdings 510(k) for the Pure-Vu EVS System for colonoscopies.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 2/11/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 2/11/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Spore Test Strip Put Into Class 2
Federal Register notice: FDA classifies the spore test strip into medical device Class 2 (special controls).
Federal Register
Class 2 for Predictive Cardiovascular Indicator
Federal Register notice: FDA classifies the adjunctive predictive cardiovascular indicator into medical device Class 2 (special controls).
Medical Devices
Senseonics Continuous Glucose Monitor Approved
FDA approves a Senseonics Holdings next-generation Eversense E3 continuous glucose monitoring system and its use for up to six months.
