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Hi-Tech Cosopt Exclusivity Debated

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Attorneys for Apotex and another generic drug company debate whether Hi-Tech has forfeited marketing exclusivity for its generic f...

Increased FDA Funding Imperiled on Hill

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The Alliance for a Stronger FDA says agreed-upon increased funding for FDA is imperiled by continuing resolution machinations in C...

Intravascular Administration Sets 510(k) Guidance

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FDA issues a guidance to assist industry to prepare 510(k) submissions for IV administration sets and accessories.

FDA Clears Digirad nSpeed SPECT Software

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FDA clears a Digirad 510(k) for its nSPEED reconstruction software intended for use in reducing single photon emission computed t...

Giuliani or Not, Ranbaxy Issues May be Tip of Iceberg

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Consulting editor John Scharmann reviews latest developments in Ranbaxys FDA woes and suggests they may be the proverbial tip of t...

FDA OKs Mylans Generic Parcopa for Parkinsons

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FDA approves a Mylan Pharmaceuticals ANDA for a generic copy of Schwarz Pharma's Parkinsons drug Parcopa.

Cell Therapeutics and FDA Reach Agreement on Zevalin sBLA

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Cell Therapeutics says that a recent meeting with FDA led to an agreement whereby data from a study called First-line Indolent Tri...

FDA: TMJ Case Depends on Definition of Serious Injury

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FDA tells the 10 Circuit Court of Appeals that the definition of serious injury used by device maker TMJ Implants in resisting fil...

FDA Corrects Harmonization Notice

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Federal Register Notice: FDA corrects a docket number in a Federal Register notice announcing the availability of Global Harmoniza...

FDA Updates 2 Drug Shortages

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FDA updates drug shortage reports on Mitozytrex and Ammonul.