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Regulatory Affairs Blog Posts

July 14, 2020 Regulatory Affairs

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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July 8, 2020 Regulatory Affairs

Understanding Cybersecurity Threats to Medical Devices

In this post, we talk about medical device cybersecurity, FDA's pre-market and…

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June 24, 2020 Regulatory Affairs

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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June 23, 2020 Regulatory Affairs

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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June 16, 2020 Regulatory Affairs

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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June 10, 2020 Regulatory Affairs

Pediatric Labeling Best Practices

Learn more about the pediatric drug development labeling guidance that helps sponsors…

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June 3, 2020 Regulatory Affairs

Best Practices to Reduce Impurities in Generics

Drugs can be rejected due to impurities. In this article, we take…

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May 27, 2020 Regulatory Affairs

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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