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Pharmacy Plus Warning on Unapproved Covid Products

[ Price : $8.95]

FDA issues Pharmacy Plus (dba Vital Care Compounder) a Warning Letter for offering unapproved drug products for prophylaxis and tr...

CBER Untitled Letter Over Unapproved Cellular Product

[ Price : $8.95]

CBER sends an untitled letter to Laguna Beach Aesthetics, Cosmetic Dermatology and Laser Center over its unapproved cellular produ...

RLC Labs Recalls Subpotent Thyroid Products

[ Price : $8.95]

RLC Labs recalls 483 lots of Nature-Throid and WP Thyroid because FDA testing of samples from six lots found them to be subpotent.

Avinger Chronic Total Occlusion Device Cleared

[ Price : $8.95]

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

De Novo Pathway for Neuro, Physical Medicine Devices

[ Price : $8.95]

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

Regulatory Review Period for Senseonics Glucose Monitor

[ Price : $8.95]

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

EUAs Announced for Four Covid-19 Drugs

[ Price : $8.95]

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

Industry Defense Shows FDA is Politically Impaired: Column

[ Price : $8.95]

Two NYU medical school professors say it shows how wounded FDA is politically when drug companies feel a need to reassure the publ...

62% of Americans Fear Vaccine Political Pressure: Poll

[ Price : $8.95]

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

Janssen sBLA for Darzalex FasPro for Amyloidosis

[ Price : $8.95]

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