Regulatory Open Forum

LOL Yes, there is a lot of toe chewing in this profession - or gnashing of teeth! Thanks for the laugh. These days, not sure I want job security any longer, retirement is looking better every day. Ginger Cantor

Hopefully someone with direct Division of Neurology experience can respond to your specific question. However, from a general regulatory strategy perspective, I would be confident that this ICH standard would be accepted across FDA. There are many factors ...

Thank you, Ames, for this summary. I am confident that the BIOSECURE Act will impact the pace of innovation among the small US biotech firms that have limited resources for development activities and have benefited from government funding and access to ...

My personal "favorite" is "The stability (or validation, or fill-in-the-blank) schedule shows the last pull date as 15 June, so we will submit by 20 June." Over the years I have spent many hours explaining to executive management that there is a great ...

Our manufacture date is indicated under the Manufacturer symbol per ISO 15223-1, as exampled in Annex A. Since we know the exact manufacturing date based on the lot number and the risk of our product is very low, Class I Exempt in the US and Class I ...