FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Federal Register Notices: Week Ending 12/25/2020

[ Price : $8.95]

Federal Register notices published the week ending 12/25/2020 while we were on our annual holiday break.

Latest FDA Warning Letters

[ Price : $8.95]

FDA Webview posts the latest Warning Letters that were released the weeks ending 12/25/2020 and 1/1/2021 while we were on our annu...

FDA Tallies 53 Novel Drug Approvals in 2020

[ Price : $8.95]

FDA approves 53 new molecular entities in 2020, which is five (10%) more than it approved in 2019 despite challenges from balancin...

Legacy Pharmaceutical Packaging FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with five observations from an inspection at Legacy Pharmaceutical Packaging, a medical device contract m...

Info Collection on FDA Fellowship Applications

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for Application for Participation in FDA Fellowship ...

FDA Proposes Human Tissue Regulations Revocation

[ Price : $8.95]

Federal Register notice: FDA proposes to revoke the regulations for human tissue intended for transplantation and human dura mater...

FDA Issues EUA for Moderna Covid-19 Vaccine

[ Price : $8.95]

FDA issues an Emergency Use Authorization (EUA) for Modernas Covid-19 vaccine for use in individuals 18 years of age and older.

Draft Guide on Dry Eye Drugs

[ Price : $8.95]

FDA posts a draft guidance entitled Dry Eye: Developing Drugs for Treatment that is intended to provide recommendations to sponsor...

Myovant Sciences Orgovyx OKd for Prostate Cancer

[ Price : $8.95]

FDA approves Myovant Sciences Orgovyx (relugolix) for treating adult patients with advanced prostate cancer.

PMA Approved for Above Knee Amputee Implant

[ Price : $8.95]

FDA approves an Integrum PMA for Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, intended for a...