FDA Related News

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.

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-...

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 ...

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.

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.

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...

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...

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.

Comments on Computer Software Assurance Guidance

Three stakeholders recommend broadening the impact of an FDA draft guidance on computer software assurance.

Medical Devices

AdvaMed Tells FDA to Scrap LASIK Labeling Guidance

AdvaMed says FDA should withdraw its draft guidance on LASIK patient labeling recommendations because the group has numerous concerns about the docume...