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Identify Barriers to Enrolling Trial Subgroups: PhRMA

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PhRMA says the FDA Office of Minority Health and Health Equity should work with industry to identify and publicize best practices ...

Panel to Discuss Mallinckrodts NDA for Terlipressin

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Federal Register notice: FDA announces a 7/15 Cardiovascular and Renal Drugs Advisory Committee online meeting to review a Mallinc...

Stakeholder Participation for Drug User Fee Reauthorization

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Federal Register notice: FDA seeks patient and consumer advocacy groups, healthcare professionals, and scientific and academic exp...

FDA Accepts for Review Leos Talokinumab BLA

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FDA accepts for review Leo Pharmas BLA for tralokinumab to treat adults with atopic dermatitis.

Brilinta sNDA Accepted for Reducing Strokes

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FDA accepts for priority review an AstraZeneca supplemental NDA for Brilinta (ticagrelor) for reducing subsequent strokes in patie...

Survey on Physician Perceptions of Boxed Warnings

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Federal Register notice: FDA sends to OMB a proposed information collection entitled Healthcare Provider Perception of Boxed Warni...

Finalize Fecal Transplantation Guidance: Petition

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The Microbiome Therapeutics Innovation Group petitions FDA to finalize a 2016 draft guidance to specify that sponsors and manufact...

Many Drug Firms Up Prices During Pandemic: Analysis

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Politico reports that many drug companies have been raising prices during the coronavirus pandemic.

Court Says it Can Hear Paragraph IV Conversion Case

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Two Gibbons attorneys say the Delaware federal court has ruled that it has subject matter jurisdiction in a generic drug patent ca...

Study of Disclosures to Physicians on Unapproved Uses

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Federal Register notice: FDA seeks comments on a proposed information collection entitled Study of Disclosures to Health Care Prov...