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Endo BLA for Treating Buttock Cellulite

[ Price : $8.95]

Endo International files a BLA for collagenase clostridium histolyticum for treating cellulite in the buttocks.

Woodcock Sees Addiction as Top Public Health Threat

[ Price : $8.95]

CDER director Janet Woodcock says addiction currently is the most serious threat to public health.

FDA OKs Boehringer Lung Disease Drug

[ Price : $8.95]

FDA approves Boehringer Ingelheim Pharmaceuticals Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in ...

FDA Wants Weight Loss Device Feedback

[ Price : $8.95]

FDA seeks comment on a discussion paper on how to determine and consider benefit and risk in weight-loss medical devices.

Seizure Drug Efficacy Extrapolation Guidance

[ Price : $8.95]

FDA issues a guidance on clinical development of drugs to treat partial onset seizures in pediatric patients over age two.

2 Humanitarian Use Guidances

[ Price : $8.95]

FDA publishes two guidances relating to humanitarian use device designations and humanitarian device exemptions.

Info Collection Extension for Patent Submissions

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension for NDA patent submission and listing requirements...

Proposal to Add 5 Bulk Drugs for Compounding

[ Price : $8.95]

Federal Register proposed rule: FDA proposes to add five additional bulk drug substances to its drug compounding list.

FDA Funding Functional Capacity Assessment Tool

[ Price : $8.95]

FDA funds VeraSci research into a virtual reality functional capacity assessment tool.

Mallinckrodt Paying $15 Million in False Claims Act Case

[ Price : $8.95]

The Justice Department says Mallinckrodt is paying $15.4 million to resolve allegations that it paid illegal kickbacks to doctors ...