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FDA Class 1 Recall on Sigma Infusion Pumps

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FDA says Sigma International General Medical Apparatus has initiated a Class 1 recall involving its Sigma Spectrum Infusion Pump M...

FDA Guidance on 'Dear Doctor' Letters

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A new FDA draft guidance provides recommendations for industry on the content and format of Dear Health Care Provider (DHCP) lette...

Debate Continues on Whether FDA is Too Safety Conscious

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FDA watchers debate whether FDA has become too risk averse with medical product reviews.

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...

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...