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Continuous Pharmaceutical Manufacturing Bill In

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Reps. Pallone and Guthrie introduce bipartisan legislation to allow FDA to partner with universities as National Centers of Excell...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company PetNet Solutions.

HeartVista AI-assisted MRI Software Cleared

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FDA clears a HeartVista 510(k) to use its artificial intelligence-assisted One Click MRI acquisition software for cardiac exams.

PET Drug CGMP Issues at Petnet

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FDA warns Petnet Solutions about CGMP violations in its manufacturing of positron emission tomography drugs.

National Center for Toxicological Research Panel Meeting 12/3-4

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Federal Register notice: FDA announces a 12/3-4 Science Advisory Board to the National Center for Toxicological Research advisory ...

Class 1 for Continuous Glucose Monitor Data Systems

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Federal Register notice: FDA classifies continuous glucose monitor data management systems into Class 1 (general controls).

AstraZeneca Positive Results for Imfinzi in Lung Cancer

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AstraZeneca announces positive progression-free survival results from the Phase 3 POSEIDON trial in previously-untreated Stage IV ...

Breakthrough Status for Medtronic Heart Pump

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Medtronic gets an FDA Breakthrough Device designation for its fully implantable left ventricular assist device for patients with a...

Electronic Format for IND Safety Reports

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FDA issues a draft guidance and a final technical conformance guide on electronic submission of IND safety reports to the FDA Adve...

Drug Shortage Causes, Solutions

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An FDA-led drug shortage task force releases a report highlighting key reasons for drug shortages and potential enduring solutions...