Replies to post #167342 on Amarin Corp Plc (AMRN)

[HDGabor]

S-

Right, 2014. All industry sectors have to evolve with constant negotiations between the agencies and courts.

2016 was the last unoffical guidance.

Sorry for my "ignorance" (I did not find your relevant post.

I guess you are referring to this (see below) in the 2016 Guidance (which is the revised draft):

7. When FDA reviews an NDI notification, does the agency consider whether the prohibition in section 301(ll) of the FD&C Act applies to the use of the NDI in a dietary supplement?
No. Section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under 21 U.S.C. 355, a biological product licensed under 42 U.S.C. 262, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. When reviewing NDI notifications, FDA’s current practice is not to consider whether section 301(ll) or any of its exemptions apply to the NDI. Accordingly, a “no objection” response to an NDI notification should not be construed to be a statement that a dietary supplement containing the NDI, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act.

It was in the previous (2011) draft as:

6. When FDA reviews a NDI notification, does the agency consider whether the prohibition in section 301(ll) applies to the use of the NDI in a dietary supplement?
No. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under 21 U.S.C. 355, a biological product licensed under 42 U.S.C. 262, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. When reviewing NDI notifications, FDA’s current practice is not to consider whether section 301(ll) or any of its exemptions apply to the NDI. Accordingly, a “no objection” response to a NDI notification should not be construed to be a statement that a dietary supplement containing a NDI, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

If for other section, please let me know.

Best,
G