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Apple Clearances Timing Raises Questions

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Attorney Bradley Thompson says an FDA announcement of the faster-than-usual clearance of two Apple products the day before a produ...

Group Seeks Removal of Black Box on Contrast Agents

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International Contrast Ultrasound Society petitions FDA urging it to remove boxed warnings from ultrasound contrast agents based o...

Pharmaceutical Laboratories and Consultants Warned

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FDA warns Pharmaceutical Laboratories and Consultants about repeat CGMP violations and other issues in its work as a contract labo...

FDA Denies Vaccine Safety Petition

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FDA denies a 2009 petition asking it to recall vaccines containing unsafe ingredients.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include ITG-Medev, Jabones Y Productos and Pharmaceutical Laboratories and C...

Oncologic Drugs Committee Renewed for 2 Years

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Federal Register notice: FDA announces the renewal of its Oncologic Drugs Advisory Committee for an additional two years beyond th...

Panel Meeting Docket Corrected

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Federal Register notice: FDA corrects a notice entitled Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeti...

FDA Clears WAT Medical Migraine Device

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FDA clears a WAT Medical 510(k) for its HeadaTerm for treating migraine headaches.

New Reimbursement Scheme for New Antibiotics Needed: FDA

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Severing FDAs historical independence from drug economics, commissioner Scott Gottlieb suggests that new innovative payment/reimbu...

Info Collection on Compounding Bulk Drug Substances

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Federal Register notice: FDA seeks comments on a proposed information collection entitled Clinical Use of Bulk Drug Substances Nom...