FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Peptide Clinical Pharmacology Guidance

[ Price : $8.95]

FDA publishes a draft guidance with clinical pharmacology considerations to assist industry in developing peptide drug products.

Risk-Based Approach to Therapeutic Protein DDI

[ Price : $8.95]

CDER Office of Clinical Pharmacology policy lead Qin Sun uses a podcast to explain the agencys risk-based approach to evaluating d...

CDISC Study Tabulation Model Version 3.4

[ Price : $8.95]

Federal Register notice: CDER and CBER announce that support begins for version 2.0 of the Clinical Data Interchange Standards Con...

FDA May Not be Ready for LDT Rule: Attorney

[ Price : $8.95]

Attorney Allyson Mullen sees the potential for chaos if FDA tries to implement its proposed rule on laboratory-developed tests wit...

Oncology Drug Dose Optimization Often Deferred: Analysis

[ Price : $8.95]

More than half of all oncology drugs approved by FDA in the last decade had a postmarketing requirement to obtain better dosing (o...

FDA Approves Next-Gen Lap-Band

[ Price : $8.95]

FDA approves a ReShape Lifesciences PMA supplement for the companys next-generation Lap-Band 2.0 FLEX, an implant indicated for we...

First Psychedelic NDA Filing Claimed for PTSD Therapy

[ Price : $8.95]

MAPS Public Benefit Corp. files what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine ca...

Phathom Pharma Files NDA for Heartburn

[ Price : $8.95]

FDA accepts for review a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) as a daily treatment for heartburn associated with ...

Guide on DTC Quantitative Efficacy/Risk Info

[ Price : $8.95]

FDA issues a revised final guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Pro...

Device CEO Pleads Guilty in Covid Test Scheme

[ Price : $8.95]

Former Decision Diagnostics CEO Keith Berman (Westlake Village, CA) pleads guilty to securities fraud, wire fraud, and obstruction...