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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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Aug 22

Corporate Compliance & Liability: What Medical Product Professionals Need to Know

Aug 23

What CDER Can and Can’t Do: An Inside Look from an Agency Official

Aug 23

Clinical Trials in the Precision Medicine Era: New Techniques, New Complexity

Sep 10

Mastering EU Medical Device Regulation

Sep 12

Top Tips for Establishing Device Supplier Quality Metrics: Develop a World-Class Program to Boost…

Sep 17

Medical Device Quality & Compliance Institute 2018: Quality Systems and Design Control Training

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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.
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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.

GLAXOSMITHKLINE AWARDED $274 MILLION HHS CONTRACT AND NOVARTIS, GOVERNMENT IN $220M FLU PACT

KEYWORDS Daily International Pharma Alert
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GlaxoSmithKline has been awarded a $274 million contract from the U.S. Department of Health and Human Services (HHS) to speed the development of new cell culture-based seasonal and pandemic influenza vaccines and to scale-up cell culture manufacturing capability at its Marietta, PA facility.

Financial News USA (http://www.financialnewsusa.com/release.php?rlsid=5040)