FDA Related News

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Three stakeholders recommend broadening the impact of an FDA draft guidance on computer software assurance.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AdvaMed says FDA should withdraw its draft guidance on LASIK patient labeling recommendations because the group has numerous concerns about the docume...

Medical Devices

Roche Molecular Gets EUA for Monkeypox Test

FDA issues Roche Molecular Systems an emergency use authorization for its cobas MPXV monkeypox test.

Medical Devices

FDA Clears Surgical Augmented Reality Software

FDA clears a Xironetic 510(k) for its IntraOpVSP augmented reality (AR) visualization software for use in complex surgeries.

Biologics

Protalix, Chiesi Resubmit Fabry Disease BLA

Protalix BioTherapeutics and Chiesi Global Rare Diseases resubmit a BLA for PRX102 (pegunigalsidase alfa) for treating adult patients with Fabry disea...

Human Drugs

Roche Alzheimers Drug Misses in 2 Phase 3 Studies

Roche says results from two Phase 3 studies evaluating Alzheimers therapy gantenerumab were not statistically significant in slowing clinical decline....