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Consumer advocates say FDA should either find that a Ranbaxy ANDA for generic Nexium is ready for immediate approval and market en...[ Price : $8.95]
A joint FDA advisory committee panel votes 18-3 that the overall benefit/risk profile of Rextoro (testosterone undecanoate) was no...[ Price : $8.95]
Federal Register Proposed order: FDA proposes to reclassify salivary stimulatory system into Class 2.[ Price : $8.95]
Federal Register Final order: FDA classifies tryptase test system devices into Class 2.[ Price : $8.95]
FDA approves Vivus and Auxiliums Stendraa as an erectile dysfunction treatment that may be taken as early as 15 minutes before sex...[ Price : $8.95]
FDA issues a special controls guideline to support classification of a tryptase test system into Class 2 (special controls).[ Price : $8.95]
Attorneys John Lavelle and Jacqueline Gorbey say medical device companies should ensure that they provide technical support reques...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: ANDA Submissions Refuse-to-Receive Standards.