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