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Well let me start with this: both "To Register and Listing" are different and need to be submitted separately. Company A and C: both are considered as manufacturer and need to register their site with FDA. While Company B: is just a sponsor: A firm that does not participate in the manufacture or ...

New chemical entity (NCE) is, according to the US FDA, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act A new molecular entity (NME) is a drug that contains an active moiety that ...

For any fixed combination trial it is recommend to consult with FDA within the pre-IND stage for any doubts and queries. If you are asking for Regulatory Considerations for fixed dose combination products, here are some important factors: -Information necessary to justify the proposed combination ...

Hi Arthur, If you are talking about studies exempt from the IDE regulations, for those studies IRB review is still required. FYI: FDA guidance document. ------------------------------ Amit Jain United States ------------------------------

They come under cosmetics in Canada. (It all depends on ingredients used in the product) Here is the link for Cosmetic product category, where you can find the category for lubricants as well. Also attached is the presentation from cosmetic division of health Canada. ------------------------------ ...