FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Lilly Sees Alzheimers Drug Decision Delay

[ Price : $8.95]

Eli Lilly says that an FDA review decision for its experimental Alzheimers drug donanemab has been pushed back to the first quarte...

Clinical e-Thermometer Enforcement Policy

[ Price : $8.95]

FDA posts a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.

Enforcement Guide on PMA/HDE Modifications

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Certain Supplements for Approved Pre...

Fix Pulse Oximeter Biases, 25 State AGs Tell FDA

[ Price : $8.95]

The attorneys general from 25 states list six things FDA should do immediately to address the concern that pulse oximeters are not...

FDA Seeking Diabetes DHT Info

[ Price : $8.95]

CDRH asks for public comments on several questions to help it advance the development of digital health technologies for use in di...

FDA OKs Abbott HPV Diagnostic Test

[ Price : $8.95]

FDA approves Abbotts Alinity m molecular human papillomavirus (HPV) diagnostic test.

Monoclonal Antibody Manufacturing Changes Research

[ Price : $8.95]

FDA researchers look at manufacturing changes and comparability assessment of FDA-approved monoclonal antibodies and Fc-fusion pro...

I-Mab Gets Breakthrough for Nephropathy

[ Price : $8.95]

FDA grants I-Mab a breakthrough therapy designation for felzartamab, an investigational CD38 antibody for treating primary membran...

FDA Continues Device Supplement Guidance

[ Price : $8.95]

FDA says it will continue to exercise enforcement discretion for some supplements to PMAs and HDEs.

FDA OKs Keytruda in Biliary Tract Cancer

[ Price : $8.95]

FDA approves Mercks Keytruda (pembrolizumab) for use with gemcitabine and cisplatin for locally advanced unresectable or metastati...