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Category: Regulatory

Preparing for DSCSA Track and Trace Implementation
Counterfeit drugs have become big business. In 2019, it was estimated that $200 billion worth of counterfeit...
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Patent Cliff 2.0: How to Leverage the 351(k) Pathway for Biosimilars
More than $198 billion in global prescription drug sales are at risk from patent expirations between...
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Analytical Testing for Drug Development
How do you ensure that your active pharmaceutical ingredients, their starting materials and intermediates,...
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What Are the Advantages of Using QbD?
For any pharmaceutical company with a drug candidate, the objective is to provide safe and effective...
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