FDA’s Emergency Use Authorization (EUA) to Combat the Coronavirus

How Emergency Use Authorization is shaping the regulatory landscape of Healthcare during the COVID-19 pandemic.
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How to Utilize CAPA in 10 Easy Steps

Step by step instructions on navigating your Corrective Action & Preventive Action (CAPA) for FDA.
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5 Ways to Stay Compliant with 21 CFR Part 11

Learn how to stay compliant with FDA's Part 11 in the age of automation!
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A Quick & Easy Guide to FDA Pre-Submissions

A simple guide to conquering your Pre-Submission Meeting with FDA, plus some free tools!
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20 New FDA Biological Approvals in 2019

A comprehensive table of CBER's 20 new biological approvals and their corresponding approval dates, intended uses, and companies.
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48 New Drug FDA Approvals in 2019

A comprehensive table of the 48 new drug approvals and their corresponding active ingredients, diseases, estimated sales, and companies.
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