Articles by Albert Yehaskel
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Interacting With The FDA — Best Practices For Drug Development Success
4/6/2017
When it comes to dealing with and interacting with the FDA, attitude plays an important part in ensuring the agency is on your side. How do you do this?
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10 Critical Components Of A Successful Global Drug Development Plan
9/30/2016
We use plans every day to help us arrive at our desired destinations. Pilots utilize flight plans prior to take off — although they have flown to their destination perhaps hundreds of times before, they nevertheless reviews and follows a flight plan. Likewise, ship’s captains also file plans and chart courses. Road maps provide guidance on how to drive from point A to point B, though today most people rely on electronic global positioning systems (GPS) to assist with navigation.
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Overcoming Challenges In Preparing CMC Dossiers — Tips For Success
6/3/2016
Preparing a chemistry, manufacturing, and control (CMC) dossier can be a daunting task. It is a detail-oriented undertaking, and as the saying goes, the devil is in the details. There are four main questions that need to be addressed for getting it right the first time: