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Helius Neuromodulation Stimulator De Novo Submission

[ Price : $8.95]

Helius Medical Technologies seeks de novo clearance of the portable Neuromodulation Stimulator device for treating chronic balance...

Sanofi Settles SEC Case for $20.2 Million

[ Price : $8.95]

Sanofi settles a Securities and Exchange Commission probe into alleged illegal payments to government officials and healthcare pro...

Latest FDA Warning Letter

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes one medical product company Zimmer Biomet.

Changes Sought in Biologics Meeting Draft Guidance

[ Price : $8.95]

Pfizer and Lilly seek changes to an FDA guidance on formal meetings between FDA and sponsors or applicants of Biosimilar User Fee ...

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.