Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

SAFORIS NDA ACCEPTED BY FDA

MGI Pharma has announced that the new drug application (NDA) for Saforis (glutamine in UpTec) Powder for Oral Suspension has been accepted for priority review by the FDA.

One pivotal Phase III trial and several supportive studies form the foundation of the NDA. The Phase III trial of Saforis was successfully completed in 326 patients with breast cancer who were receiving anthracycline-based chemotherapy regimens. The primary endpoint of this trial, defined as a reduction in incidence and severity of oral mucositis, was met.

Recommended Products

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Biological Risk Evaluation and Management for Medical Devices

Events

MDR Adverse Event Codes for Devicemakers

Getting Real About Real World Evidence: Practical Next Steps for Drug and Device Manufacturers

Commissioner Gottlieb’s FDA: His First Year and a Look Ahead

Corporate Compliance & Liability: What Medical Product Professionals Need to Know

Clinical Trials in the Precision Medicine Era: New Techniques, New Complexity

What CDER Can and Can’t Do: An Inside Look from an Agency Official

Editor's Picks

7D Surgical’s Cranial Module Device Receives FDA Approval

NICE Reverses Decision to Reject Besponsa

SAFORIS NDA ACCEPTED BY FDA

Related Products

Regulatory Challenges of Device Acceptance

eCTD Submissions — What You Need to Know to Comply with FDA Requirements - Webinar Recording/Transcript

Medical Device Calibration: A Step-by-Step Guide to Meeting FDA and ISO Standards

Related Events

13th Annual FDA Inspections Summit

Commissioner Gottlieb’s FDA: His First Year and a Look Ahead

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers