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Category: Regulatory
Preparing for DSCSA Track and Trace Implementation
September 30, 2022
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
April 29, 2022
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
November 01, 2021
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?
October 01, 2021
For any pharmaceutical company with a drug candidate, the objective is to provide safe and effective...
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