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FDA Approves Higher Dose of Ozempic Diabetes Drug

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FDA approves a 2 mg dosage level of Novo Nordisks diabetes drug Ozempic.

Info Collection on Clinical Investigator Disclosures

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Federal Register notice: FDA sends to OMB an information collection extension entitled Financial Disclosure by Clinical Investigat...

FDA Provides More Details on Legislative Proposals

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FDA releases an executive summary that provides more details on the package of legislative proposals that were included in the age...

CISA Philips e-Alert Advisory

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The federal Cybersecurity & Infrastructure Security Agency identifies a vulnerability in the Philips e-Alert MRI monitoring platfo...

FDA Releases 2 FDA-483s for Zhejiang Hisun

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FDA releases the FDA-483 issued following two 2017 inspections at Chinas Zhejiang Hisun Pharmaceutical Company.

FDA Questions Modest Benefit in ALS Drug

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An FDA advisory committee briefing document released in advance of a 3/30 panel meeting shows the agency is skeptical of the data ...

Device Rule Reduces Paper Copy Submissions

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Federal Register final rule: FDA amends the medical device regulations to update mailing address information and to reduce the num...

Animal Drug Regs Amended for Approvals

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Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug app...

Senator Scott Urges FDA to Fill Vacancies

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Senator Rick Scott (R-FL) urges FDA to fill vacant management posts at CDER and CBER because FDA is too important an agency to ope...

FDA Budget Request Seeks $2.1 Billion Spending Boost

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FDA outlines a $2.1 billion (34%) boost in its fiscal year (FY) 2023 proposed spending plan as part of president Bidens just-relea...