FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Arbor Nymalize Suit Looks at FDA Product Withdrawal Reasons

[ Price : $8.95]

Attorney Sarah Cork describes an Arbor Pharmaceuticals suit challenging an FDA determination that the companys withdrawal of its o...

20 NDAs Not Withdrawn Due to Safety/Efficacy: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that 20 drug products were not withdrawn from sale for safety or effectiveness reasons.

Boston Scientific Paying $189 Million to Settle State Mesh Cases

[ Price : $8.95]

California says it will receive $19 million as part of a $189 million Boston Scientific settlement with 47 states and the District...

4 Goals in CBER Strategic Plan

[ Price : $8.95]

CBER releases its strategic plan for 2021-2025 with four goals that reflect the Centers near-term priorities.

Tempus Breakthrough for ECG Analyzer

[ Price : $8.95]

FDA grants Tempus a breakthrough device designation for its artificial intelligence electrocardiogram Analysis Platform.

Exela Wants Nicardipine PDUFA Fee Refund

[ Price : $8.95]

Exela petitions FDA to reassign a therapeutic equivalence code to its nicardipine NDA product and refund PDUFA user fees that it b...

FDA Revises Bulk Drug Substances Listing

[ Price : $8.95]

Federal Register notice: FDA revises its list of bulk drug substances (active pharmaceutical ingredients) for which there is a cli...

Workshop on Generic Drug Science/Research Initiatives

[ Price : $8.95]

Federal Register notice: FDA announces a 6/23 public workshop entitled FY 2021 Generic Drug Science and Research Initiatives Works...

Refusal to File Letter for Novo Nordisk Semaglutide

[ Price : $8.95]

FDA issues a refusal to file letter for a Novo Nordisk semaglutide label expansion application.

No Need Now for Insulin, Growth Hormone Product Guidance: FDA

[ Price : $8.95]

FDA denies a 2006 request from four state governors to issue product-specific guidance for the development of insulin and human gr...