FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Lawmakers Ask FDA to Weigh in on EpiPen Alternatives

[ Price : $8.95]

Lawmakers write to FDA asking what it can do to ensure approval of competitive alternatives to Mylans EpiPen (epinephrine injectio...

FDA Guidance on Microbiology Data for Antibacterial Drugs

[ Price : $8.95]

FDA releases a guidance on Microbiology Data for Systemic Antibacterial Drugs Development, Analysis, and Presentation that is int...

Complete Response Letter for Amgens Parsabiv

[ Price : $8.95]

FDA issues a complete response letter for Amgens Parsabiv NDA.

Lilly to Appeal Adverse Axiron Court Decision

[ Price : $8.95]

Lilly says it will appeal an Indiana federal court ruling allowing generic forms of its Axiron testosterone drug.

FDA Cautions on Syringe Pump Flow Problems

[ Price : $8.95]

FDA cautions healthcare professionals that programmable syringe pumps can have flow continuity problems when used to infuse therap...

FDA Guide on ANDA Refusals Related to Impurity Limits

[ Price : $8.95]

FDA posts a guidance on ANDA Submissions Refuse to Receive for Lack of Justification of Impurity Limits that is intended to help...

Drug Prices Set on What Market Will Bear: Study

[ Price : $8.95]

Harvard Medical School researchers say that high U.S. drug prices are caused primarily by FDA-awarded market exclusivity and paten...

Court Rejects Homeopathic Labeling Suit Settlement

[ Price : $8.95]

A California federal court cites recommendations from seven attorneys general in rejecting a proposed settlement in a homeopathic ...

FDA Clears Amedica Expanded Valeo II Lateral Lumbar

[ Price : $8.95]

FDA clears an Amedica 510(k) for expanded Valeo II Lateral Lumbar sizes.

Drug, Device Recalls Up in 2nd Quarter

[ Price : $8.95]

The Stericycle Recall Index shows that drug and medical device recalls were up in the second quarter of 2016 over first quarter to...