FDA Related News

Medical Devices

FDA Update on Heater-Cooler Devices

FDA provides an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have ...

Human Drugs

Objectionable Conditions in 2 Clinical Trials

FDA warns Smitha Reddy and her Poway, CA-based ACRC Studies facility about objectionable conditions in conducting two clinical investigations.

Human Drugs

Outsourcing Facility Producing Illegal Drugs: FDA

FDA warns Deerfield Beach, FL-based Hybrid Pharma about multiple violations in its work as an outsourcing facility.

Human Drugs

Alnylam Pharma Amyloidosis Therapy Approved

FDA approves an Alnylam Pharmaceuticals NDA for Amvuttra (vutrisiran), an RNAi therapeutic administered by subcutaneous injection once every three mon...

FDA Draft Trial Diversity Guidance Outlined

Troutman Pepper attorneys discuss a new FDA draft guidance giving sponsors information on presenting diversity plans to enroll under-represented popul...

Human Drugs

FDA Makena Advisory Committee Set for Mid-October

The presiding officer for a hearing on a CDER proposal to withdraw approval for Covis Makena says the hearing will be held 10/17-10/19.

Human Drugs

Do More to Promote Generic Competition: White Paper

A Brookings Institution white paper lists six policy changes FDA could make to enhance generic drug competition.

Califf on Tweaking Accelerated Approvals, No Big Revamp

FDA commissioner Robert Califf says a total revamp of the drug accelerated approval program is not needed to answer criticism following a number of dr...

Human Drugs

Whole-of-Governments Approach to Illicit Medical Products

FDA says it is working with the Organization of Economic Cooperation and Development on a whole-of-governments approach to fighting illicit medical pr...

Medical Devices

FDA to Study Breast Implant Risk Perception

FDA says it is funding a study of patient perceptions of the risk of a specific cancer associated with textured breast implants.