Complete Response Letters
Acer Therapeutics Inc.: sodium phenylbutyrate
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 15, 2022
Drug, and Cosmetic Act for sodium phenylbutyrate.
CRL_NDA214860_20220615:p1:s12Satisfactory inspection is required before this application may be approved.
CRL_NDA214860_20220615:p1:s19Submit draft carton and container labeling based on our proposed revisions and communications dated May 24, 2022, and May 31, 2022.
CRL_NDA214860_20220615:p1:s44Summarize the relevance of this information to the dose of talc contained in 20 g of your proposed sodium phenylbutyrate product.
CRL_NDA214860_20220615:p2:s31More Complete Response Letters
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