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New DTC Major Statement Standards Become Effective

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New FDA advertising standards require drug marketers to ensure their direct-to-consumer advertisements major statement is presente...

Preserve Covid-19 Vaccine Records: Senator

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Republican Sen. Ron Johnson orders FDA, HHS, and CDC to preserve all records relating to Covid-19 vaccines, saying they will be su...

CDER Deputy Throckmorton Retiring in January

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CDER deputy director for regulatory programs Doug Throckmorton announces his retirement after 27 years at the agency.

PCCP Draft Guidance Stakeholder Recommendations

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Two stakeholders request changes to an FDA draft guidance on predetermined change control plans for medical devices.

FDA Revokes EUAs on Covid Tests

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Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Cue Health for the Cue Covid19 Test, and Cue Covid...

FDA Provides More Draft ANDA-Specific Guidances

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug sponso...

Fludarabine Phosphate Labeling Changes OKd

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FDA announces approved labeling changes for Sandoz fludarabine phosphate injection under the Oncology Center of Excellences Projec...

FDA Clears Ultromics EchoGo Amyloidosis Device

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FDA clears an Ultromics 510(k) for the EchoGo Amyloidosis for detecting cardiac amyloidosis.

Sage Ending Dalzanemdor Development

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Sage says it is ending dalzanemdor development in Huntingtons disease cognitive impairment following Phase 2 DIMENSION results tha...

FDA Warns Unexo Lifesciences Over CGMP

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FDA warns New Delhi, India-based Unexo Lifesciences about CGMP and other violations in its production of finished drugs.