Newsletter - January 25, 2018
Government Shutdown and FDA: Should Pharma Care or Not?
Last weekend, the US government was shut down for two and half days and there is talk that another shutdown may happen in 3 weeks. Since such events are becoming more common than they ought to be, it is important for the FDA regulated industry to understand the impact of the government shutdown on FDA’s functions and any preparation to deal.. Read More
FDA Explains its Wish List for Quality Overall Summary in NDAs and BLAs
FDA published a white paper this week to explain what its reviewers wish to see in the Quality Overall Summary (QOS) giving some useful and practical tips to improve the marketing approval applications. Module 2 of an NDA, ANDA and BLA application contains the QOS which summarizes the manufacturing.. Read More
Government Shutdown and FDA: Should Pharma Care or Not?
Last weekend, the US government was shut down for two and half days and there is talk that another shutdown may happen in 3 weeks. Since such events are becoming more common than they ought to be, it is important for the FDA regulated industry to understand the impact of the government shutdown on FDA’s functions and any preparation to deal.. Read More
FDA Explains its Wish List for Quality Overall Summary in NDAs and BLAs
FDA published a white paper this week to explain what its reviewers wish to see in the Quality Overall Summary (QOS) giving some useful and practical tips to improve the marketing approval applications. Module 2 of an NDA, ANDA and BLA application contains the QOS which summarizes the manufacturing.. Read More
