FDA Related News

Human Drugs

FDA Approves Evoke Gimoti Brand Name

FDA conditionally accepts Gimoti as the brand name for an Evoke Pharma diabetic gastroparesis nasal spray product.

Human Drugs

Pandemic Adverse Event Reporting Guidance

FDA issues a guidance on adverse event reporting priorities during the Covid-19 pandemic.

Biologics

Source Plasma Donor Screening Guidance

FDA issues a guidance recognizing donor history questionnaires prepared by the Plasma Protein Therapeutics Association.

Woodcock, Marks Out of Covid Vaccine Review

FDA commissioner Stephen Hahn says CDER director Janet Woodcock and CBER director Peter Marks will recuse themselves from all regulatory consideration...

Federal Register

Web Conference on ICH Good Clinical Practice

Federal Register notice: FDA announces a 6/4-5 public Web conference to discuss the International Council for Harmonizations good clinical practice gu...

Human Drugs

Karyopharm sNDA for Xpovio

Karyopharm Therapeutics files a supplemental NDA for Xpovio (selinexor), indicated as a new treatment for patients with previously treated multiple my...

Medical Devices

Groups Issue Facility Device Rep Reentry Guidance

AdvaMed joins two national health organizations in suggesting guidelines for allowing medical device company representatives back into hospitals and o...

Human Drugs

Pharmacovigilance/Risk Management Training Web Cast

FDA announces a 6/9-10 Web cast entitled Pharmacovigilance and Risk Management Conference New Approaches, Tools, and Technologies.

Medical Devices

Zebra Medical 510(k) for Vertebral Compression Fractures

FDA clears a Zebra Medical Vision 510(k) for its Vertebral Compression Fractures (XXX DELETE XXX)) product, an artificial intelligence solution that a...

Medical Devices

QS Violations Seen in Lymol Medical Inspection

FDA warns Lymol Medical about multiple Quality System and Medical Device Reporting violations in its manufacturing of a bronchoscope system and silico...