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Alcon Pulls CyPass Micro-Stent from Market

[ Price : $8.95]

Alcon withdraws from the market its CyPass Micro-Stent for surgical glaucoma due to safety concerns documented in a five-year stud...

Pfizer Petitions FDA on Premarin Bioequivalence

[ Price : $8.95]

Pfizer petitions FDA to tighten bioequivalence requirements for any ANDA submitter seeking to gain approval for generic copies of ...

Info Collection on Testing FDA Communications

[ Price : $8.95]

Federal Register notice: FDA seeks comments on a new proposed information collection entitled Generic Clearance for Quantitative T...

Info Collection Extension of Device Labeling

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension entitled Medical Device Labeling Regulations 21 C...

Safety Alert on Recalled Montelukast Sodium Tablets

[ Price : $8.95]

FDA issues a safety warning following a Camber Pharmaceuticals recall of one lot of montelukast sodium tablets.

Compass Health Recalls CPAP Mask Cushion Seals

[ Price : $8.95]

Compass Health Brands recalls its continuous positive airway pressure mask cushion seals due to possible air leaks.

FDA Clears Quidels Sofia 2 Lyme Immunoassay

[ Price : $8.95]

FDA clears a Quidel 510(k) for its Sofia 2 Lyme Fluorescent Immunoassay and its use with the Sofia 2 Fluorescent Immunoassay Analy...

Sunovion Gets Rejection Letter on ADHD Drug

[ Price : $8.95]

FDA issues Sunovion Pharmaceuticals a complete response letter rejecting its NDA for dasotraline, a novel dual-acting dopamine and...

Bayer Hemophilia Therapy Jivi Approved

[ Price : $8.95]

FDA approves Bayers Jivi for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 ye...

Pilot Meetings for Innovative Trial Designs

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Federal Register notice: FDA announces a pilot meeting program to allow sponsors to discuss the use of complex innovative trial de...