FDA Related News

Medical Devices

Avinger Chronic Total Occlusion Device Cleared

FDA clears an Avinger 510(k) for its TigerEye image-guided chronic total occlusion crossing system.

Medical Devices

De Novo Pathway for Neuro, Physical Medicine Devices

FDA holds a Webinar to explain the de novo pathway for use with new neurological and physical medicine devices.

Federal Register

Regulatory Review Period for Senseonics Glucose Monitor

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Senseonics Eversense Continuous Glucose Monitor...

Federal Register

EUAs Announced for Four Covid-19 Drugs

Federal Register notice: FDA announces the issuance of four emergency use authorizations for drugs for use during the Covid-19 pandemic.

FDA General

Industry Defense Shows FDA is Politically Impaired: Column

Two NYU medical school professors say it shows how wounded FDA is politically when drug companies feel a need to reassure the public that they wont di...

62% of Americans Fear Vaccine Political Pressure: Poll

The September Kaiser Family Foundation health tracking poll shows that many people fear that political pressure will force FDA to rush approval of a C...

Biologics

Janssen sBLA for Darzalex FasPro for Amyloidosis

Janssen Pharmaceutical Companies files a supplemental BLA for Darzalex FasPro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of dara...

Human Drugs

FDA Warns 17 Web Sites Illegally Selling Opioids

FDA warns 17 Web site operators that they are illegally selling unapproved and misbranded opioids.

8 FDA Execs Say Agency is Following the Science

The eight top FDA career executives write in a USA Today opinion piece that they are committed to following the science within the political environme...

Human Drugs

FDA Holds Up Sarepta Gene Therapy Trial

FDA trepidation with gene therapies continues as it holds up a Sarepta Therapeutics clinical trial by asking for an additional potency assay to releas...