As per the post published on FDA law blog.....
Late last week while those of us in the U.S. were still digesting our turkey dinners, FDA issued a draft guidance document describing the Agency’s current thinking on the implementation of § 4(b)(1) of the Q1 Program Supplemental Funding Act (Pub. Law No. 110-379) (“the Q1 Act”)........
The details can be read here.
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