FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Too Few Older Adults in Trials: Study

[ Price : $8.95]

FDA and academic researchers say the representation of older adults in clinical trials should be improved.

Changes Urged in ANDA Amendments Appendix

[ Price : $8.95]

Three stakeholders suggest specific changes to Appendix A of the ANDA Amendments guidance as called for in the GDUFA 3 negotiation...

Califf Still Seeking Revamp of Accelerated Approval

[ Price : $8.95]

FDA commissioner Robert Califf tells the 2022 National Organization for Rare Disorders Breakthrough Summit that improvements in th...

Breast Density Notification Rule Due Soon: DeLauro

[ Price : $8.95]

Rep. Rosa DeLauro says FDA has told her a mandated new rule on breast density notification should be issued by early 2023.

Multiple Violations at Beijing Xinggu Lvsan

[ Price : $8.95]

FDA warns Chinas Beijing Xinggu Lvsan about CGMP violations in its illegal marketing of misbranded unapproved new drugs.

Draft Guide on Tissue Agnostic Drug Development

[ Price : $8.95]

FDA posts a draft guidance entitled Tissue Agnostic Drug Development in Oncology. The document provides recommendations to sponsor...

Settino Permanently Debarred by FDA

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Gregory Settino from providing services related to an approved ...

Guide on Immune-mediated Adverse Reactions

[ Price : $8.95]

FDA posts a draft guidance entitled Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunoth...

Medtronic Modifies Software for HeartWare Pump Problem

[ Price : $8.95]

Medtronic announces that a backup controller with modified software can be used if the primary controller fails to restart its Hea...

Guide on Acute Myeloid Leukemia Therapies

[ Price : $8.95]

FDA makes available a final guidance entitled Acute Myeloid Leukemia (AML): Developing Drugs and Biological Products for Treatment...