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Countermeasure Priority Review Voucher Fee $2.5 Million

[ Price : $8.95]

Federal Register notice: FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for...

Joint Panel to Review Sage Postpartum Depression Drug

[ Price : $8.95]

Federal Register notice: FDA announces an 11/2 joint advisory committee meeting to review a Sage Therapeutics NDA for its proposed...

Draft Guide on Good Review Management

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Good Review Management Principles and Practices for New Dru...

Guide on ANDA Submission Content and Format

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled ANDA Submissions Content and Format.

Biologic Product Marketplace Competition Comments

[ Price : $8.95]

Two stakeholders provide comments on an FDA public hearing on biologic product marketplace competition.

Comments on Drug Administration Vehicles

[ Price : $8.95]

Six drug companies give FDA comments and recommendations on a draft guidance on using liquids and/or soft foods as drug administra...

Find New Ways to Fund Pediatric Research: Study

[ Price : $8.95]

A study of pediatric exclusivity trials finds that they have yielded useful information, but at a very high cost to consumers.

OrthoXel Fracture Nailing System Cleared

[ Price : $8.95]

FDA clears an OrthoXel 510(k) for the Apex Tibial Nailing System, a fracture fixation device that can be surgically implanted from...

HHS Cancels FDA Fetal Tissue Contract

[ Price : $8.95]

HHS cancels an FDA fetal tissue contract with Advanced Biosciences Research and opens an investigation into all fetal tissue resea...

Endo Extends Stay on Vasopressin Suit Against FDA

[ Price : $8.95]

Endo extends the stay on a suit against FDA following an agency commitment to finalize its clinical need determination for vasopre...