The FDA July 12 and 13 will hold a public workshop and meeting on "The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers."
FDA
Simplifying Global Compliance
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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.
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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Health Canada Opens Consultation on ‘Pause the Clock’ Proposal
The agency would be able to pause the clock for medical device applications linked together that have different review times.
FDA Approves First Immuno-Oncology Drug for Certain Patients Previously Treated for Lung Cancer
The agency said continuing approval for Opdivo may depend on the drug showing clinical benefit in future clinical trials.