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Gmp-inspection-preparation-checklist-130x160

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Dec 11

ICH E6 GCP Interactive Workshop

Dec 12

Building a World-Class Advertising and Promotion Review Program

Dec 12

Transforming Quality Management with Modern Technology

Dec 18

Medical Device Voluntary Malfunction Disclosure Regulation: Are You Up to Date on the…

Dec 18

Medical Device Cybersecurity Risks & Best Practices: Navigating the Nuanced Cyber Regulatory Waters

Jan 10

Sampling Plans for Quality Audits

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FDA to Address ‘Narrow’ Labeling of In Vitro Companion Devices for Oncology Drugs

FDA Commissioner Scott Gottlieb noted an increase in new drugs targeting specific molecular markers that drive the growth and spread of cancer.
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Gilead’s HIV Drug Approved in China

Descovy received FDA and European Commission marketing approval in 2016.

CURAGEN INITIATES SECOND VELAFERMIN TRIAL

KEYWORDS Drug Pipeline Alert
A A

CuraGen has announced the initiation of patient dosing in a Phase II clinical trial evaluating a single dose of velafermin for the prevention of oral mucositis (OM).

This clinical trial, the second Phase II study of velafermin, is designed to assess the safety and efficacy of velafermin for the prevention of OM in cancer patients receiving high-dose chemotherapy, with or without radiotherapy, in the setting of autologous bone marrow transplantation (BMT).