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I am not aware of a specific regulation or guidance related to IND applications. My concept of this is based on the regulations and guidance related to 505(b)(2) NDA applications where it is pretty well defined how a product that relies on FDA review of an approved product is addressed. Such an application ...

A letter of authorization from Merck would not be required unless you want to rely on information owned by Merck that was not reviewed as part of a marketing authorization application. ------------------------------ Glen Park PharmD Consultant Burien WA United States ------------------------------

I can highly recommend conferences sponsored by the Food and Drug Law Institute. This organization is geared toward the lawyers that practice FDA law. The regulatory profession does not exist without FDA law and regulations. ------------------------------ Glen Park PharmD Consultant Burien WA United ...

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 to consider in how FDA might respond but it is ...

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 economical manufacturing and research solutions ...