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CDER Guidance Coming on Quality Metrics Initiative

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CDER says it will publish a draft guidance on its Quality Metrics Initiative by the end of the year.

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FDA issues a draft guidance to say that it does not intend to consider whether firms that provide a declaration of conformity and ...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

FDA Character Space Limitations Guidance Draws Fire

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Trade organizations say that an FDA draft guidance on manufacturer communication on Internet/social media platforms with character...

Industry Seeks Context in HHS Reports on MD Payments

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Three industry trade groups ask CMS to make sure there is background contextual information when the agency begins reporting physi...

FDA Urged to Reconsider Misinformation Draft Guidance

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Trade organizations ask FDA to scale back a draft guidance on responsibility for correcting product misinformation posted by third...

Be Sure FDA Promotes Biologic Drug Access: Dellums

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Former Rep. Ron Dellums says the decision FDA makes on how to name biosimilars can affect how successful the Affordable Care Act i...