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Medical Devices

NEST Unique Device Identifier Playbook

The NEST Collaborating Community issues a draft playbook on using medical device unique device identifiers at the point of care.

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Human Drugs

GSK Reports Favorable Data from TB Therapy Trial

GSK says a Phase 2a study showed that GSK3036656, an investigational antitubercular agent, was well tolerated and showed early bactericidal activity w...

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Human Drugs

GEs DaTscan Expanded Dementia Use OKd

FDA approves an expanded use for GE Healthcares DaTscan (ioflupane I 123 injection) for use in patients with suspected dementia with Lewy Bodies.

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Human Drugs

Lupin Hit with Another FDA-483

FDA issues a five-item Form FDA-483 after conducting a pre-approval inspection of Lupins Nagpur, India Unit-2 injectable manufacturing facility 10-17-...

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Human Drugs

Pass PASTEUR Act Before Congress Ends: 165 Groups

Some 165 healthcare-related organizations urge Congress to pass the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act before the ...

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Medical Devices

FDA Updates Cybersecurity Playbook

FDA says MITRE has updated a 2018 playbook explaining how healthcare organizations can prepare for and respond to cybersecurity incidents.

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Human Drugs

Certain Naloxone Products Could be OTC: FDA

FDA is soliciting comments on a preliminary assessment that some naloxone products may be safe and effective when sold over-the-counter.

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Human Drugs

FDA Questions Ardelyx Tenapanor

FDA medical reviewers ask the Cardiovascular and Renal Drugs Advisory Committee to consider whether the benefits of Ardelyx tenapanor outweigh its ris...

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Medical Devices

Workshop on Using Consensus Standards in Device Submissions

FDA announces a 12/7 public workshop on Appropriate Use of Consensus Standards to obtain public input on using these in premarket submissions for medi...

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Human Drugs

1 Observation on Athenex Pharma FDA-483

FDA releases the form FDA-483 issued following an inspection at the Clarence, NY-based Athenex Pharma Solutions outsourcing facility.