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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...

FDA OKs Siemens Somatom X.cite CT Scanner

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FDA clears a Siemens Healthineers 510(k) for the Somatom X.cite premium single-source computed tomography scanner and its myExam C...

FDA OKs Medtronic In.Pact Balloon

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FDA approves a Medtronic PMA for the In.Pact AV drug-coated balloon, a paclitaxel-coated balloon indicated for treating failing ar...

Industry Attacks Dems Drug Price Plan

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Three major pharmaceutical sector stakeholders say an analysis they commissioned shows that the number of new medicines would drop...

eCTD Promotion Submission Errors

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CDER OPDP lead project manager Jason Cober reviews in a Webinar the types of errors being seen in promotional submissions in eCTD ...