FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

California Could Partner in Drug Manufacturing: Report

[ Price : $8.95]

Attorney Sara Koblitz says Californias governor is considering signing legislation that would make the state a partner in drug man...

Guidance on Eosinophilic Esophagitis Drug Development

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Eosinophilic Esophagitis: Developing Drugs for Treatment.

FDA Misinterpreted Law in Goprelto Case, Court Says

[ Price : $8.95]

The DC federal court says FDA misinterpreted the FFDCA when it approved Lannetts Numbrino during the new chemical entity exclusivi...

Azar Overruled Hahn on Covid Test Jurisdiction: Politico

[ Price : $8.95]

Politico reports exclusively that HHS secretary Alex Azar ordered FDA to stop evaluating laboratory-developed tests over the objec...

Public Workshop on Drug Integrated Assessments

[ Price : $8.95]

FDA announces a 10/30 virtual public workshop on New Drugs Regulatory Program Modernization: Implementation of the Integrated Asse...

Software Pre-Cert Program Far from Operational: Report

[ Price : $8.95]

SheppardMullin attorneys say FDA seems to be years away from implementing its pilot software pre-certification program.

Class 1 Recall on Alaris Pump Syringe/PCA Modules

[ Price : $8.95]

FDA classifies as Class 1 a recall involving a Becton Dickinson CareFusion recall of its Alaris Syringe and Alaris PCA Modules due...

CBER Lists 29 Guidances in CY 2020 Agenda

[ Price : $8.95]

An updated CBER guidance agenda for 2020 lists 29 planned guidances in four categories.

GEs Shatterproof Bulk Package for Contrast Agent OKd

[ Price : $8.95]

FDA approves GE Healthcares shatterproof polymer +PLUSPAK Pharmacy Bulk Package for use with its macrocyclic gadolinium-based MRI ...

Comments on IND Communications with FDA

[ Price : $8.95]

Three drug industry stakeholders give FDA feedback on its public meeting on an independent assessment of FDA-sponsor IND communica...