FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

ICH Publishes E6 Good Clinical Practice Draft

[ Price : $8.95]

The International Council for Harmonization publishes a draft version of its E6 good clinical practice guideline.

EMA Adds Warning to J&J Vaccine; Supports Use

[ Price : $8.95]

A European Medicines Agency safety review says Johnson & Johnsons Covid-19 vaccine continues to have a favorable benefit-risk prof...

KalVista Trial in Hereditary Angioedema on Hold

[ Price : $8.95]

FDA places a clinical hold on a KalVista Pharmaceuticals proposed Phase 2 clinical trial of KVD824 for preventing hereditary angio...

Medtronic Bio-Console 560 Perfusion System Recall Class 1

[ Price : $8.95]

FDA says a Medtronic recall of 93 units of its Bio-Console 560 blood pumping console due to potential electrical failure is Class ...

Topics Discussed at 2 PDUFA 7 Pre-Market Subgroup Meetings

[ Price : $8.95]

FDA releases summaries of two PDUFA 7 negotiating sessions by the FDA/industry pre-market subgroup.

Latest FDA Warning Letter

[ Price : $8.95]

FDA releases its latest batch of Warning Letters that includes one medical product company Hou Fu Biotech.

Zimmer Biomet Rosa Partial Knee Cleared

[ Price : $8.95]

FDA clears a Zimmer Biomet 510(k) for the Rosa Partial Knee System for robotically-assisted partial knee replacement surgeries.

Clarify What SiMD is Included in SaMD Plan: AdvaMed

[ Price : $8.95]

AdvaMed says FDA should apply the same policies to software in a medical device that it applies to software as a medical device.

7 Topics Discussed at 2nd MDUFA 5 Reauthorization Meeting

[ Price : $8.95]

FDA releases a summary of discussions on seven topics at the second MDUFA 5 reauthorization negotiation meeting.

5 Reps Bill Would End Mandatory Animal Testing

[ Price : $8.95]

A bipartisan group of House members introduces legislation to end mandatory animal testing in drug development.