Federal Circuit Junks Boston Scientific Win in Stent Patent Fight

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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.

Events

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Jan 17

Recent Developments in ICH Harmonization: Lifecycle Management, Biowaivers & Bioanalytical…

Jan 30

Regulating Software Used by Life Science Manufacturers: Is it a Medical Device or Not?

Feb 13

Building a World-Class Drug Supply Chain: Tips for Compliance and Digital Transformation

Feb 19

Medical Device Risk Management: Prepare for the Winds of Change

Mar 20

Medical Device Complaint Management: Escape the Labyrinth

Mar 26

Conducting Advanced Root Cause Analysis and CAPA Investigations

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FDA Brings Back More Staff for Inspection Activities

Approximately 100 staff members will carry out inspections of high risk medical device manufacturing facilities.

Sen. Sanders, Rep. Cummings Introduce Bill Package to Lower Drug Costs

Rep. Khanna said the bill “will bring down drug prices by taking on monopolies and boosting prescription drug competition.”