FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guidance on Liposome Drug Products

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Liposome Drug Products: CMC; Human Pharmacokinetics and Bioavailability; a...

510(k) Devices Take 94% of Post-market Surveillance Studies: GAO

[ Price : $8.95]

A Government Accountability Office analysis of FDA-ordered postmarket surveillance studies between 3/2008 and 2/2015 finds that 94...

Comments Re-opened on Adipose Tissue Guidance

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on a draft guidance: Human Cells, Tissues, and Cellular and Tissue-Based P...

CDRH Draft Guidance on Device Electromagnetic Compatibility

[ Price : $8.95]

CDRH posts a draft guidance on Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medic...

Lipocine NDA Filed for Testosterone Product

[ Price : $8.95]

FDA accepts for filing a Lipocine NDA for LPCN 1021, an oral product candidate for testosterone replacement therapy in adult males...

Guidance on Homologous Use of Human Cells et

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Prod...

OMB OKs Info on Generic Drug Correspondence

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on correspondence ...

FDA Issues Revised Liposome Guidance

[ Price : $8.95]

FDA issues a revised guidance on information needed with an application for liposome drug products reviewed by CDER.

FDA Extends Dispenser Tracing Info Deadline

[ Price : $8.95]

FDA revises a product tracing compliance guidance to give more time before it takes enforcement action against drug dispensers who...

Stakeholders Appreciate Registry Report

[ Price : $8.95]

Stakeholders say they generally support a Medical Device Registries Task Force report on a national medical device evaluation syst...