FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Warns Unexo Lifesciences Over CGMP

[ Price : $8.95]

FDA warns New Delhi, India-based Unexo Lifesciences about CGMP and other violations in its production of finished drugs.

FDA Finds CGMP Violations in Originitalia Inspection

[ Price : $8.95]

FDA warns Italys Originitalia about CGMP violations in its production of finished drugs.

Put Semaglutide Drugs on DDC Lists: Novo Nordisk

[ Price : $8.95]

Novo Nordisk petitions FDA to take specific steps to follow through on the companys nomination of semaglutide (Rybelsus, Ozempic, ...

CGMP Violations at Silliker Contract Lab

[ Price : $8.95]

FDA cautions Silliker contract testing laboratory about CGMP violations at its Gainesville, FL, facility.

Toms of Maine CGMP Issues

[ Price : $8.95]

FDA warns the Colgate-Palmolive Toms of Maine unit about CGMP violations in its manufacturing of finished drugs.

Cell/Gene Therapy Product Frequent Questions

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Frequently Asked Questions Developing Potential Cellular a...

Jesduvroq Not Withdrawn Over Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that GlaxoSmithKlines Jesduvroq (daprodustat) tablets were not withdrawn due to safety or ...

Advisors Asked About Generative AI Regulation

[ Price : $8.95]

FDA asks members of its Digital Health Advisory Committee to spend two days discussing agency questions about its role in regulati...

Astellas Gets Complete Response on Izervay sNDA

[ Price : $8.95]

FDA sends Astellas Pharma a complete response letter on a supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) ...

Stakeholder Comments on Oncology Trial Guidance

[ Price : $8.95]

Three stakeholders raise concerns about an FDA draft guidance on considerations for generating clinical evidence from multiregiona...