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Replacement Reagent Instrument Family Policy Guidance

[ Price : $8.95]

FDA publishes an updated guidance on replacement reagent and instrument family policy for in vitro diagnostic devices.

CGMP Violations at Verde Cosmetic Labs

[ Price : $8.95]

FDA warns Northridge, CA-based Verde Cosmetic Labs about CGMP violations in its production of finished drugs.

NIH Did Not Ensure Trial Reporting: OIG

[ Price : $8.95]

The HHS Office of Inspector General says the National Institutes of Health failed to enforce federal requirements that clinical tr...

Drug Inspections at Operational Levels: Throckmorton

[ Price : $8.95]

Attorney Douglas Farquhar says FDA speakers at a GMP conference indicated that domestic drug facility inspections are back at oper...

Emergent BioSolutions Warning Letter Out

[ Price : $8.95]

FDA warns Baltimore, MD-based Emergent BioSolutions about repeat CGMP violations in its manufacturing of finished drugs.

Case Safety Report Transmission Guide

[ Price : $8.95]

FDA publishes a regional implementation guide for an International Council on Harmonization document on electronic transmission of...

Roche sBLA for Polivy in Large B-Cell Lymphoma

[ Price : $8.95]

FDA accepts for review a Roche supplemental BLA for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus...

FDA Priority Review for Lynparza sNDA

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FDA accepts for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with abiraterone and predni...

Comments Sought on ANDA Submissions Guide

[ Price : $8.95]

Federal Register notice: FDA establishes a docket to solicit comments on the content of Appendix A in the 7/2018 guidance for indu...

New Drug Launch Prices This Year Jump 43%: Analysis

[ Price : $8.95]

A new drug pricing analysis finds that for drugs launched so far this year, their median pricing ($257,000) is 43% more than the m...