MERCK TO BUY GLYCOFI, ABMAXIS FOR $480M

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Events

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Oct 17

Quality Metrics Redux: Taking Advantage of FDA’s Renewed Focus

Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Oct 23

13th Annual FDA Inspections Summit

Oct 30

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

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Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

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FDA Warns Becton Dickinson for Potentially Contaminated Water, Environmental Conditions

The company promised to discontinue use of tap water.

FDA Releases 25 Product-Specific Guidances for Generics

“In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections,” said FDA Commissioner Scott Gottlieb.