FDA Related News

Federal Register

Info Collection on IND Sponsor Surveys

Federal Register notice: FDA submits to OMB a new information collection entitled Surveys and Interviews With Investigational New Drug (IND) Sponsors ...

Medical Devices

510(k) Substantial Equivalence Guidance Explained

CDRH biomedical enginer Ifeanyi Uwemedimo explains provisions in a newly-finalized guidance on benefit-risk assessments for 510(k) submissions.

Human Drugs

FDA Wants More Informed Consent Flexibility

FDA says it wants to give institutional review boards some greater flexibility to waive or alter informed consent requirements under some conditions.

Human Drugs

Steps Needed to Speed Biosimilar Market Entry: Study

Harvard Medical School researchers outline several steps that FDA and Congress could take to increase the number of biosimilars available to patients.

Medical Devices

Lumendi 510(k) for Endoscopic Polyp Surgery

FDA clears a Lumendi 510(k) for its DiLumen EIP technology with suture loops placed in the skirt along the trailing edge of the fore balloon, a modifi...

Human Drugs

Ardelyx NDA Accepted for Irritable Bowel Drug

FDA accepts for review an Ardelyx NDA for tenapanor for treating patients with irritable bowel syndrome with constipation.

Medical Devices

Repeat QS Violations in US Vascular Inspection

FDA warns US Vascular about Quality System and Medical Device Reporting violations in its production of VascuLab devices used in vascular pathology.

StemGenex Product Does Not Meet Legal Requirements: FDA

FDA warns StemGenex about multiple violations in its production of a stromal vascular fraction product.

Marketing

FDA to Study Oncology Drug Professional Promotion Disclosures

FDA describes professional promotion research it wants to conduct about oncology drug disclosures.

Drug Recalls Up 19% in 2018 Q3: Stericycle

The Stericycle Recall Index for the third quarter of 2018 shows an increase in drug recalls and a decrease in medical device recalls.