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Comments Sought on Device Mfr. Electronic Submissions

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Federal Register Notice: FDA seeks comments on the agency requirement that device establishments submit registration and listing i...

FDA Accepts Qnexa NDA for Obesity

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FDA accepts for review a Vivus NDA resubmission for Qnexa to treat obesity.

Abbott Sues Perrigo Over Androgel Patent Infringement

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Abbott sues Perrigo for Androgel patent infringement after Perrigo files an NDA for testosterone gel 1%.

Glaxo to Pay $3 Billion to Settle Marketing Probes

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GlaxoSmithKline expects to finalize a $3 billion settlement with the federal government in 2012 to resolve a number of outstanding...

Researcher Criticizes FDA Chantix Studies, Conclusions

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Researchers say that Pfizers Chantix has too many neuropsychiatric risks to be used as a first-line smoking cessation treatment.

TechneLite Panel Omits Risk Info

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CDERs Office of Prescription Drug Promotion says that a Lantheus TechneLite exhibit board omits important risk information and mak...

Enhanced Safety Surveillance for TNF Blockers

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FDA says enhanced tumor necrosis factor manufacturer surveillance of malignancies in children and young adults will help it better...

FDA OKs Luitpold Generic Elestat

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FDA approves a PharmaForce/Luitpold Pharmaceuticals ANDA for a generic version of Merck's Elestat.

Multiple Promotion Violations at Busulfex Web Site

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CDERs Office of Prescription Drug Promotion says that an Otsuka Busulfex Web site omits material facts, makes unsubstantiated clai...

Public Workshop on Developing Sedation Products

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Federal Register Notice: CDER plans a public workshop on the clinical development of sedation products in adults and pediatric age...