Improving Cost Efficiency, Speed, and Completeness of Generic Applications
Working with an FDA consultant can improve the cost efficiency, and help…
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Understanding Cybersecurity Threats to Medical Devices
In this post, we talk about medical device cybersecurity, FDA's pre-market and…
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How Should You Respond & React When Employees Become Infected...
Minimize the risk of a COVID-19 outbreak in your manufacturing facility, while…
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How Opioid Analgesic Drugs are Approved by the FDA
The benefit-risk assessment is the cornerstone of how all drugs are approved.…
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3 Factors to Consider in the Manufacturing Phase for Drug...
Combination products represent an important and growing category of therapeutic and diagnostic…
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Pediatric Labeling Best Practices
Learn more about the pediatric drug development labeling guidance that helps sponsors…
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Best Practices to Reduce Impurities in Generics
Drugs can be rejected due to impurities. In this article, we take…
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Medical Device Regulation in the EU in the Midst of...
How have the regulations changed due to the current global health crisis…
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