FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guide on Population Pharmacokinetics

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Population Pharmacokinetics.

Guide on Drug Pressor Effects

[ Price : $8.95]

Federal Register notice: FDA makes available a revised draft guidance entitled Assessment of Pressor Effects of Drugs.

Class 2 for Apple Irregular Heart Rhythm Monitor

[ Price : $8.95]

Federal Register notice: FDA classifies Apples photoplethysmograph analysis software for over-the-counter use into medical device ...

Cytokinetics NDA for Heart Failure Drug

[ Price : $8.95]

FDA accepts for review a Cytokinetics NDA for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin act...

Califf Vows Tough Accelerated Approval Enforcement

[ Price : $8.95]

In a move to gain Senate backing of his FDA commissioner nomination, Robert Califf promises once in office to crack down on drug c...

Clinical Trial Diversity Bill Introduced

[ Price : $8.95]

Three Congressional representatives introduce bipartisan legislation intended to increase diversity in clinical trials.

Pfizer, Ionis Bail on Vupanorsen Development

[ Price : $8.95]

Pfizer and Ionis say they are discontinuing a development program for vupanorsen for potential cardiovascular risk reduction.

Clinical Pharmacology Report Out

[ Price : $8.95]

The FDA Office of Clinical Pharmacology issues its 2021 annual report with an outlook for 2022.

FDA Looking at Ukoniq Death Risk

[ Price : $8.95]

FDA suspends enrollment of new patients in all Ukoniq trials while it evaluates a potential risk of increased death seen in the UN...

FDA Nixes 2011 Proposal on Drug Supply Security

[ Price : $8.95]

Federal Register notice: FDA withdraws a 7/14/2011 proposed rule entitled Removal of Certain Requirements Related to the Prescript...