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FDA Adds Medical Device Cybersecurity Standard

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FDA recognizes UL 2900-1 as a medical device cybersecurity standard.

FDA Public Meeting on Pediatric Big Data

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FDAs Office of Pediatric Therapeutics announces a 9/18-19 public workshop entitled Advancing the Development of Pediatric Therapeu...

Stakeholders Support Records Guidance

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Stakeholders offer support for an FDA draft guidance on electronic records and signatures, with recommendations to improve it.

CDRH Mailing Address Change for Device Classifications

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Federal Register final rule technical amendment: FDA is amending the Medical Device Classification Procedures regulation to reflec...

Trump Signs User Fee Reauthorization Bill

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President Trump signs the FDA Reauthorization Act of 2017 that renews the agencys user fee programs for another five years.

FDA Reviewing Opioid Use for Treating Pediatric Coughs

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FDA says it is carefully evaluating prescription opioid medications approved to treat cough in children, and it has planned a 9/11...

Regulatory Review Period for Dog Pain Drug was 2,092 Days

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Federal Register notice: FDA determines the patent restoration purposes the regulatory review period for Acrux DDS Pty. Ltd.s Recu...

Form 483 Posted for Florida Drug Outsourcer

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A July inspection at outsourcing drug manufacturer Leesar, Inc. (Fort Myers, FL) finds that the firms aseptic processing areas wer...

CDER, ORA Pen Operational Agreement for Inspections

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CDER and ORA announce a concept of operations agreement to integrate facility evaluations and inspections for human drugs.

Orphan Status for Syros Pharmas Leukemia Therapy

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FDA grants Syros Pharmaceuticals an orphan drug designation for SY-1425 for treating acute myeloid leukemia.