Archive for February 23rd, 2015

FDA Issues New Guidance on cGMP for Combination Products – A Quick Review

In January 2015 the FDA issued a new draft  guidance document regarding the final rule on current good manufacturing practice requirements (cGMP) for combination products that was issued on January 22, 2013 and made effective on July 22, 2013. The guidance describes and explains the final rule, so it is important for all combination product manufacturers to understand the most influential topics that were covered. Read more »