FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Microbot Single-Use Robotic Endovascular System Cleared

[ Price : $8.95]

FDA clears a Microbot Medical 510(k) for its Liberty Endovascular Robotic System, a single-use, remotely operated device for perip...

MAHA Reports Aims to Improve Kids Health

[ Price : $8.95]

A MAHA Commission report assessing the health of American children suggests a couple of ways in which FDA could improve the situat...

CGMP API Deviations at Hikal Limited

[ Price : $8.95]

FDA warns Jigani, Karnataka, India-based Hikal Limited about CGMP deviations in its production of active pharmaceutical ingredient...

Issues in 3 Trials Conducted by Detroit Doctor

[ Price : $8.95]

FDA warns Detroit, MI-based medical oncologist Shirish Gadgeel about bioresearch monitoring violations in his conduct of three cli...

Former CBER Therapeutics Deputy Anatol Joins Lilly

[ Price : $8.95]

Eli Lilly hires former CBER Office of Therapeutic Products (OTP) deputy director Rachael Anatol, who was removed from her agency p...

FDA Posts 2 Biosimilar Development Guides

[ Price : $8.95]

FDA releases two final guidances related to biosimilar development: One on comparative analytical assessments, and the other on cl...

Firm Pays $40 Million Over Adulterated Gowns

[ Price : $8.95]

Kimberly-Clark agrees to pay $40 million under a deferred prosecution agreement to resolve a criminal charge that it sold adultera...

Gottlieb Warns HHS Could Undermine Pediatric Vaccines

[ Price : $8.95]

Former FDA commissioner Scott Gottlieb warns that HHS secretary Robert F. Kennedy Jr. may attempt to use a forthcoming HHS report ...

FDA Guidance on Good Clinical Practice Principles

[ Price : $8.95]

FDA issues an updated guidance entitled E6(R3) Good Clinical Practice (GCP) that describes GCP principles, emphasizing flexible, m...

Lillys Jaypirca Shows Major Benefit in Leukemia Trial

[ Price : $8.95]

New trial data show Eli Lillys Jaypirca (pirtobrutinib) significantly extended progression-free survival in previously untreated p...