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Attorneys for Apotex and another generic drug company debate whether Hi-Tech has forfeited marketing exclusivity for its generic f...[ Price : $8.95]
The Alliance for a Stronger FDA says agreed-upon increased funding for FDA is imperiled by continuing resolution machinations in C...[ Price : $8.95]
FDA issues a guidance to assist industry to prepare 510(k) submissions for IV administration sets and accessories.[ Price : $8.95]
FDA clears a Digirad 510(k) for its nSPEED reconstruction software intended for use in reducing single photon emission computed t...[ Price : $8.95]
Consulting editor John Scharmann reviews latest developments in Ranbaxys FDA woes and suggests they may be the proverbial tip of t...[ Price : $8.95]
FDA approves a Mylan Pharmaceuticals ANDA for a generic copy of Schwarz Pharma's Parkinsons drug Parcopa.[ Price : $8.95]
Cell Therapeutics says that a recent meeting with FDA led to an agreement whereby data from a study called First-line Indolent Tri...[ Price : $8.95]
FDA tells the 10 Circuit Court of Appeals that the definition of serious injury used by device maker TMJ Implants in resisting fil...