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FDA OKs Glaxo Boostrix Vaccine in Adults

[ Price : $8.95]

FDA approves GlaxoSmithKlines Boostrix vaccine [tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorb...

Erbitux BLA Submitted for Lung Cancer

[ Price : $8.95]

ImClone Systems submits a BLA for Erbitux (cetuximab) to expand the drugs use to include first-line treatment of patients with adv...

OTC Adverse Event Label Requirements Clarified

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CDER provides guidance for OTC drug labels to give a reporting address or phone number for serious adverse events.

Risk Panel to Discuss Info Available to Patients

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Federal Register Notice: FDAs Risk Communication Advisory Committee will meet 2/6 to discuss information available on medication g...

Sandoz Downplays Big Heart Drug Recall

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Consulting editor John Scharmann reviews Sandoz Inc.s efforts to downplay manufacturing issues with one of its cardiovascular drug...

Terumo Cardiovascular Recalls Pediatric Device

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Terumo Cardiovascular Systems recalls 21 lots of its Tenderflow Pediatric Arterial Cannulae after receiving five reports involving...

Not Waiting for Obama, CDER Pushes New Goals

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CDER director Janet Woodcock and OND director John Jenkins unveil new efforts on e-submissions, improving Center culture, review t...

No FDA Senior Official Should Get High Post: Stupak

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Rep. Bart Stupak urges President-elect Obama not to appoint any current FDA senior executive as commissioner or even interim commi...

Nissen on FDA Commissioner Attributes, Agency Needs

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Reputed FDA commissioner candidate Steven Nissen gives a Washington conference his ideas on what both that job and FDA need most.

FDA Lists Handgun as Class 1 Medical Device

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A New Jersey gun maker gets FDA designation of an ergonomically designed, barely detectable single-shot pistol as a Class 1 medica...