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SK Life Sciences Seizure Drug Approved

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FDA approves a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults.

Panel Summary on Amalgam, Other Metal Devices

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FDA posts a summary of the deliberations during an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee mee...

HHS Publishes Fall 2019 Agency Rule List

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HHS publishes the latest unified rule agenda including 85 FDA items.

Draft Guide on Transdermal/Topical Drug Delivery

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Federal Register notice: FDA makes available a draft guidance entitled Transdermal and Topical Delivery Systems Product Developme...

New Info Collection on Cosmetic Events Survey

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Federal Register notice: FDA sends to OMB a proposed information collection on Web-Based Pilot Survey To Assess Allergy to Cosmeti...

Info Collection Extension for Dear Doctor Letters

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Federal Register notice: FDA sends to OMB an information collection extension for its Guidance for Industry on Dear Health Care Pr...

FDA-483 from 2 Aurobindo Unit Inspections

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FDA releases FDA-483s from inspections at two Aurobindo units in India.

New Calquence Indication Approved

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FDA works with Australia and Canada to approve a new indication for AstraZenecas Calquence.

WLF Wants Ban on Drug Prices in Ads

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Washington Legal Foundation says the DC Court of Appeals should uphold a decision barring HHS from requiring drug companies to inc...

Academy Urges Broader Info Sharing Among Regulators

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A new report by the National Academy of Sciences recommends that regulators like FDA need to make increased use of reliance and co...