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Final Guide for ALS Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Amyotrophic Lateral Sclerosis (ALS): Developing Drugs for T...

Clinical Hold on Abeona Gene Therapy

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FDA places a clinical hold on an Abeona Therapeutics planned Phase 3 clinical trial for EB-101 until it submits additional data po...

Oncologists Respond Swiftly to FDA Safety Alerts: Study

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Researchers say oncologists can move quickly when FDA issues new safety information on therapies approved under accelerated approv...

Latest FDA Warning Letter

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

FDA Approves Jynneos Smallpox and Monkeypox Vaccine

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FDA approves Bavarian Nordics Jynneos smallpox and moneypox vaccine.

Draft Guide on Patient Input on Device Trials

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Federal Register notice: FDA makes available a draft guidance entitled Patient Engagement in the Design and Conduct of Medical Dev...

Guide on ALS Drug Development

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FDA issues a final guidance entitled Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.

Medtronics New TAVR System Approved

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FDA approves Medtronics Evolut Pro+ Transcatheter Aortic Valve Replacement System.

Guide on Complex Innovative Clinical Trial Designs

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Federal Register notice: FDA makes available a draft guidance entitled Interacting with the FDA on Complex Innovative Clinical Tri...

Guide on Device Accreditation/Conformity Pilot

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Federal Register notice: FDA makes available a draft guide entitled The Accreditation Scheme for Conformity Assessment Pilot Progr...