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Human Drugs

Continuous Pharmaceutical Manufacturing Bill In

Reps. Pallone and Guthrie introduce bipartisan legislation to allow FDA to partner with universities as National Centers of Excellence in Continuous P...

FDA General

Latest FDA Warning Letter

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

Medical Devices

HeartVista AI-assisted MRI Software Cleared

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

Human Drugs

PET Drug CGMP Issues at Petnet

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

Federal Register

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

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

Federal Register

Class 1 for Continuous Glucose Monitor Data Systems

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

Human Drugs

AstraZeneca Positive Results for Imfinzi in Lung Cancer

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

Medical Devices

Breakthrough Status for Medtronic Heart Pump

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

Human Drugs

Electronic Format for IND Safety Reports

FDA issues a draft guidance and a final technical conformance guide on electronic submission of IND safety reports to the FDA Adverse Event Reporting ...

Human Drugs

Drug Shortage Causes, Solutions

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