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Hamburg Launches Safe Use Initiative for Drugs

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Commissioner Margaret Hamburg announces the agencys Safe Use Initiative, a cooperative effort to involve health care workers and c...

InterMune Submits Pirfenidone NDA

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InterMune submits an NDA to FDA for pirfenidone to treat idiopathic pulmonary fibrosis.

Centurion Recalls Premie and Meconium Packs

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CDRH says that Centurion Medical Products is recalling its Premie and Full-Term Meconium Packs that contain a recalled Smiths Medi...

FDA Issues OTC Drug Delivery Device Guidance

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FDA issues a draft guidance on markings placed on drug delivery devices packaged with OTC liquid drug products.

Obama Losing at FDA, Too

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FDA Webview editor Jim Dickinson sees the same disappointment gap in promised Obama changes at FDA as the voters saw more generall...

FDA Posts Device Cybersecurity Reminder

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FDA reminds medical device manufacturers and users of their shared obligation to maintain cybersecurity for devices.

GenVec Drug for Pancreatic Cancer Gets 'Orphan' OK

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FDA grants GenVec, Inc.s TNFerade orphan drug and fast-track designation for treating pancreatic cancer.

FDA Grants Priority Review to Shires Gaucher Disease Therapy

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FDA grants priority review to Shires NDA for velaglucerase alfa to treat Type 1 Gaucher disease.

FDA Transparency Task Force Delves into Difficult Disclosures

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A second public meeting by FDAs Transparency Task Force examines difficult public disclosure opportunities involving NDA withdrawa...

FDA Clears Patient Monitoring System

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FDA clears an Alcatel-Lucent 510(k) for the Alcatel-Lucent TeleHealth Manager, a secure, remote patient monitoring system.