FDA Related News

Human Drugs

Mesoblast Wins Orphan Status for Revascor

FDA grants Mesoblast an orphan-drug designation for Revascor (rexlemestrocel-L) and its use in children with congenital heart condition hypoplastic le...

FDA Late with Diversity Plan Guidance

A Regulatory Affairs Professionals Society online post says FDA is several weeks late in delivering a congressionally mandated guidance on clinical tr...

Human Drugs

Fast Track for Type 1 Diabetes Drug

FDA grants Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in some diabetes patients.

Medical Devices

Merit Medicals SCOUT Surgical Guide Cleared

FDA clears a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System for use in implanting surgical reflectors in abnormal breast tissu...

Federal Register

Charging for Drugs Under an IND Guidance

FDA makes available a final guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.

Federal Register

FDA Digital Transformation Office Reorganization

Federal Register notice: FDA announces that its Office of Digital Transformation has modified its organizational structure.

Human Drugs

Professor Blasts FDA on Harmful Supplements

Harvard Medical School professor Peter Cohen blasts FDA for a lack of sufficient action to remove harmful dietary supplements from the marketplace.

Human Drugs

FDA Denies Zydus Indomethacin Suppository Petition

FDA denies a Zydus petition asking the action to take actions about the indomethacin suppository reference standard.

Human Drugs

9 Observations in Eugia Pharma Inspection

FDA releases the form FDA-483 with nine observations from an inspection at Indias Eugia Pharma Specialties sterile drug manufacturing facility.

Biologics

Citius Pharma Refiles BLA for Lymphoma

Citius Pharmaceuticals resubmits a BLA for Lymphir (denileukin diftitox) for treating patients with relapsed or refractory cutaneous T-cell lymphoma.