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FDA Pushed to Regulate Online Drug Promos

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Gardner Law says prescription drug manufacturers and marketers need to be sure their social media promotions can withstand FDA scr...

No-Longer-Marketed Enteregs Approval Withdrawn

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Federal Register notice: FDA withdraws approval of Cubist Pharmaceuticals Entereg (alvimopan) capsules because it is no longer mar...

Regulatory Review Period for B+Ls Miebo

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Bausch + Lombs eye drug Mie...

FDA Debars Ryan Stabile for 15 Years

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Federal Register notice: FDA debars Ryan Stabile for 15 years from importing or offering for import any drug into the U.S.

More FDA Stringency Seen on Accelerated Drug OKs

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Two Sheppard Mullin attorneys say sponsors of drugs approved through expedited pathways should learn from a recent FDA untitled le...

FDA Clears Cresilons Traumagel

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FDA clears Cresilons Traumagel device that uses a plant-based technology to control moderate to severe bleeding at the point of ca...

FDA Touts CDER Advanced Manufacturing Research Facility

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FDA describes CDERs new state-of-the-art advanced manufacturing research facility.

Priority Review for Imfinzi sBLA in Lung Cancer

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FDA accepts for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) and its use in certain patients with limi...

Rare Disease Status Given to Duchenne Therapy

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FDA grants Wave Life Sciences a rare pediatric disease designation for WVE-N531 and its use in treating boys with Duchenne muscula...

NexoBrid Gets Expanded Use for Pediatric Burns

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FDA approves a Vericel supplemental BLA for NexoBrid (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-...