Five Innovations That Will Define Tech in 2013, Including an FDA Battle Over Digital Health

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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...

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

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

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

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

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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.

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.