FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Fresenius Hit With 11-Item FDA-483

[ Price : $8.95]

FDA releases an 11-item Form FDA-483 from a 10/2023 Fresenius Kabi Oncology inspection at the companys Pradesh, India manufacturin...

e-Submission Guide for BIMO Inspection Planning

[ Price : $8.95]

FDA posts a final guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Biore...

Panel to Discuss Opioid Abuse Studies

[ Price : $8.95]

Federal Register notice: FDA announces a 2/5 joint meeting of its Drug Safety and Risk Management Advisory Committee and Anestheti...

Drug/Biologic Accelerated Approval Draft Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Expedited Program for Serious Conditions Accelerated Appro...

GE Healthcare Recalls Newborn Incubators

[ Price : $8.95]

GE Healthcare has recalled its Giraffe Omnibed Carestation and Incubator Carestation due to the potential for excessive formaldehy...

Groups Urge Rare Disease Voucher Reauthorization

[ Price : $8.95]

A letter from dozens of patient advocacy groups urges congressional leaders to pass the Creating Hope Reauthorization Act, which w...

FDA Loses Again in FOIA Suit on Vaccine Records

[ Price : $8.95]

A Texas federal court rules against FDA in an ongoing Freedom of Information Act lawsuit and it must now produce EUA supporting do...

FDA Finds Lab Issues at Musk Plant

[ Price : $8.95]

Reuters says FDA has informed Congress about a 2023 agency inspection at Elon Musks Neuralink that found animal lab issues that wa...

Updated Accelerated Approval Guidance

[ Price : $8.95]

FDA publishes a draft guidance updating its accelerated approval policies and procedures based on new authority from the 2023 Cons...

Genentech sBLA for Columvi Accepted for Review

[ Price : $8.95]

FDA accepts for review a Genentech supplemental BLA for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin...