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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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May 30

Cutting the Costs of Clinical Trial Subject Recruitment: Insights into Patient Outreach: Traditio...

May 31

FDA’s New Concept of Operations for Drug Inspections and Evaluations: What You Need to Do Today

Jun 5

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Jun 5

Appendix M of the NIH Guidelines: Reporting Requirements and Best Practices

Jun 6

10 Sure-Fire Tips for Developing a Document Management System Any Investigator Would Love

Jun 7

SOPs and Policies for the 21st Century: Why Less Is More

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Congress

Stakeholders Urge Congress to Update Clinical Laboratory Diagnostics Legislation

The letter to lawmakers cites an urgent need to reform regulations covering laboratory developed tests and in vitro diagnostics.
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Seniors Paying More for Generics Through Medicare Part D, Study Finds

The higher cost sharing did not correspond with an increase in the underlying price of generic drugs, Avalere said.

CHEMOKINE STARTS CANCER DRUG TRIAL

KEYWORDS Drug Pipeline Alert
A A

Chemokine has begun a Phase Ib/II trial of its anticancer candidate CTCE-9908.

The trial will enroll up to 30 patients with late-stage cancers, including breast, lung, prostate and ovarian cancer. The company said it expects to file an investigational new drug application with the FDA and expand its clinical program for CTCE-9908.

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Getting Real About Real World Evidence: Practical Next Steps for Drug and Device Manufacturers

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