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Federal Register

United Therapeutics Used Priority Voucher on Tyvaso

Federal Register notice: FDA announces that a priority review voucher was redeemed in the 5/23 approval of United Therapeutics supplemental NDA for Ty...

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Human Drugs

States Pushing for Canadian Drug Imports: Report

A Kaiser Health News report says four states have now submitted applications to import some drugs from Canada, with others signaling interest but not ...

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Human Drugs

FDA Accepts NDA for Eye Dilating Combo Product

FDA accepts for review an Eyenovia resubmitted NDA for MydCombi ophthalmic spray, a drug-device combination product that comprises tropicamide and phe...

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Federal Register

Cardio/Renal Drugs Panel Renewed for 2 Years

Federal Register notice: FDA renews for two years the charter of its Cardiovascular and Renal Drugs Advisory Committee.

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Federal Register

Info Collection on OTC Drug Labeling

Federal Register notice: FDA sends to OMB an information collection revision entitled General Drug Labeling Provisions and OTC Monograph Drug User Fee...

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Human Drugs

$2.25 mil. RWD Funding Opportunity

CDER and CBER release a $2.25 million funding opportunity announcement to assess the potential utility of real-world data to generate real-world evide...

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Human Drugs

CGMP Deviations Seen in Centrient Inspection

FDA warns Indias Centrient Pharmaceuticals about significant CGMP deviations in its manufacturing of active pharmaceutical ingredients.

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FDA General

Clinicians Need Refresher on Clinical Trial Statistics: Survey

Researchers conclude clinicians are challenged to interpret results from both Bayesian and traditional statistical outputs from clinical trials and ne...

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Medical Devices

Whats Behind the New LASIK Guidance?

Attorney Jeffrey Shapiro says FDA appears to be trying to get LASIK laser manufacturers who have an approved PMA to submit a supplement for new patien...

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Human Drugs

Bill to Advance Pregnant/Lactating Women in Trials

Representatives Kathy Castor (D-FL), Brian Fitzpatrick (R-PA), and Lauren Underwood (D-IL) introduce HR 9487, Advancing Safe Medications for Moms and ...