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More Than 1,000 Breakthrough Device Designations

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FDA says it has granted breakthrough device designation to 1,041 devices from 2015 through the 9/30 end of the 2024 fiscal year.

FDA Approves PTC Therapeutics Kebilidi

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FDA approves PTC Therapeutics Kibilidi as the first gene therapy to treat aromatic L-amino acid decarboxylase deficiency.

Home AFib Blood Pressure Monitor De Novo Granted

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FDA grants a de novo marketing authorization to Omron Healthcare for its new home blood pressure monitors featuring AI-powered atr...

Medical Device Recalls Up, Drugs Down: Sedgwick

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The Sedgwick third quarter 2024 recall index documents an increase in medical device recalls and a decrease in drug recalls.

SonoMotion De Novo for Stone Clear Ultrasound

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FDA grants SonoMotion a de novo marketing authorization for its Stone Clear device for the ultrasound treatment of post-lithotrips...

False or Misleading Xeomin Promotion: FDA

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FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring celebrity spokesman Nate Berku...

Adaptimmune Therapeutics Plan Lete-Cel BLA

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Adaptimmune Therapeutics plans a rolling BLA submission for cell therapy lete-cel in certain people with synovial sarcoma or myxoi...

7 Observations on U.S. Specialty FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility i...

Oligonucleotide-Based Therapeutic Assessment

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FDA publishes a draft guidance on the nonclinical safety assessment of oligonucleotide-based therapeutics.

NovaBone Putty Cleared for Intervertebral Disc Repair

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FDA clears a NovaBone Products 510(k) for its NovaBone Putty and its expanded use in the intervertebral disc space.