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FDA Targets Improvements With External Defibrillators

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FDA warns external defibrillator makers that device problems and recalls need to improve or the industry will face tougher premark...

FDA Clarifies Animal Drug Regs for Minor Use/Species

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Federal Register Direct final rule/proposed rule: FDA updates the language and clarifies the regulations in its regulations on new...

Change of Animal Drug Sponsor to Pegasus

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Federal Register Final rule: FDA changes its animal drug regulations to reflect a change of sponsor for sulfadiazine and pyrimetha...

FDA OKs Vyvanse for Adolescent ADHD

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FDA approves a Shire NDA for Vyvanse capsules for treating attention deficit hyperactivity disorder in adolescents ages 13 to 17.

FDA Approves Halaven for Late-Stage Breast Cancer

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FDA approves Eisai Inc.s Halaven, a synthetic form of a compound derived from a sea sponge, to treat patients with metastatic brea...

Hill FDA Oversight to Intensify Under Republicans: FDA Matters

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FDA Matters editor Steven Grossman predicts more intense oversight and investigation hearings on Capitol Hill after the Republican...

Mercury Hazard from Amalgam Greater than Thought: 2 Studies

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A month before it hears critics of its 2009 dental amalgam rule that the device is safe, FDA is confronted by two new studies cont...

FDA Grants Sangart Orphan Drug for Sickling Crises

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FDA grants Sangart, Inc. orphan drug designation for MP4CO for use in treating acute sickling crises in patients with sickle cell ...

FDA Backs Get Smart About Antibiotics Week

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FDA partners with CDC and other groups to support Get Smart About Antibiotics Week to educate consumers about the proper use of an...

DDMAC Cites Misbranded Vivitrol Materials

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DDMAC says an Alkermes patient welcome kit for Vivitrol (naltrexone) is misbranded because it minimizes important risk information...