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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

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Six drug companies give FDA comments and recommendations on a draft guidance on using liquids and/or soft foods as drug administra...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

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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

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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

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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

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

16 Observations in Pharm D Solutions FDA-483

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FDA releases the FDA-483 with 16 observations from an inspection at the Pharm D Solutions outsourcing facility.

Neurelis NDA for Epilepsy Nasal Spray

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Neurelis files an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experienc...

Renovid Surgical 3D-printed Interbody Fusion System Cleared

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FDA clears a Renovis Surgical Technologies 510(k) to market the Tesera X Lateral Interbody Fusion System.

FDA Publishes 3 Drug Compounding Guidances

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FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of r...