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Hi Nancy, Obviously this is one of those situations that regulatory folks deal with probably every day so it is a timely discussion just in general. To me, the first thing is not to "argue" your case - especially in front of senior leadership. I would start during the meeting with a response that ...

Hi folks. Hopefully have a quick question - our company is in the consumer product space (cosmetics, OTC, personal care, etc.) and we are trying to figure out a way to stay ahead (or at least up-to-date) of packaging material requirements globally. As an example, the French have put out a ban on ABS ...

Hi Ryan. This is always a fun question to answer (I do a lot of career fairs for people from middle school through college) and is always one that gets a lot of conversations going. Before I go on, let me make it clear that I am in an area of regulatory that is rather different from many (possibly ...

Hi Sapna. Simply put and as I explained in a previous thread - OTC products are still drugs. So all of the standard rules in 21 CFR 210/211 will apply to OTC products with the only real exception being that if the product is formulated and labeled in compliance with a monograph that is currently in ...

Hi Anon. I actually completely agree with Kevin's position on this one. You really should not reasonably be considering any "KPI" less than 100% in this case. First, there is a legal obligation under the regulations in the US and most other jurisdictions that puts a time limit on how long you have ...