FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 8/31/2018.
Federal Register
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 8/31/2018.
Human Drugs
Alcon Pulls CyPass Micro-Stent from Market
Alcon withdraws from the market its CyPass Micro-Stent for surgical glaucoma due to safety concerns documented in a five-year study.
Human Drugs
Pfizer Petitions FDA on Premarin Bioequivalence
Pfizer petitions FDA to tighten bioequivalence requirements for any ANDA submitter seeking to gain approval for generic copies of its Premarin (conjug...
Federal Register
Info Collection on Testing FDA Communications
Federal Register notice: FDA seeks comments on a new proposed information collection entitled Generic Clearance for Quantitative Testing for the Devel...
Federal Register
Info Collection Extension of Device Labeling
Federal Register notice: FDA submits to OMB an information collection extension entitled Medical Device Labeling Regulations 21 CFR Parts 800, 801, a...
Human Drugs
Safety Alert on Recalled Montelukast Sodium Tablets
FDA issues a safety warning following a Camber Pharmaceuticals recall of one lot of montelukast sodium tablets.
Medical Devices
Compass Health Recalls CPAP Mask Cushion Seals
Compass Health Brands recalls its continuous positive airway pressure mask cushion seals due to possible air leaks.
Medical Devices
FDA Clears Quidels Sofia 2 Lyme Immunoassay
FDA clears a Quidel 510(k) for its Sofia 2 Lyme Fluorescent Immunoassay and its use with the Sofia 2 Fluorescent Immunoassay Analyzer.
