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Comments Sought on Veterinary Feed Directive Reporting

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on reporting and recordkeeping requirements for use of Veterinary Feed Directive drugs...

Guidance on Fluoroscopic Equipment Requirements

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Federal Register Notice: FDA releases a draft guidance: Policy Clarification for Fluoroscopic Equipment Requirements.

FDA Publishes Approved PMA List

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Federal Register Notice: FDA publishes a list of approved PMAs and their safety and effectiveness summaries.

Ala. Court Decision Raises Many Questions: Attorney

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Attorney Bert Rein calls for a new pharmaceutical product liability regime nationally to eliminate the inadequacies and inequities...

Coalition Seeks Hamburg Firing Over Opioid Approvals

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A coalition of anti-opioid addiction advocates asks HHS secretary Sylvia Burwell to fire FDA commissioner Margaret Hamburg over th...

Fluoroscopic Equipment Guidance Out

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FDA issues a draft guidance to say that it does not intend to consider whether firms that provide a declaration of conformity and ...

CDER Awards $16.2 mil Contract for Drug Use Data

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CDER announces a $16.2 million contract to Source Healthcare Analytics to obtain prescription and patient-level drug use data.

Pfizers Chantix Wins Relaxed Label on Suicidality

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FDA approves new labeling that softens a warning on Pfizers smoking cessation drug Chantix (varenicline) about suicidality.

FDA Approves Noven Pharmaceuticals Minivelle for Osteoporosis

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FDA approves a Noven Pharmaceuticals supplemental NDA for a new indication with a new dose of Minivelle (estradiol transdermal sys...

Baxter, Merrimack Form Pact on Pancreatic Cancer Therapy

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Baxter International and Merrimack Pharmaceuticals enter into a licensing and development agreement for nanoliposomal irinotecan, ...