Submitted February 2, 2018 - USP Comment Letter on on the Food and Drug Administration's (FDA) Draft Guidance "ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of DNA Origin." Docket No. FDA-2017-D-5767.
Submitted February 2, 2018 - USP Comment Letter on on the Food and Drug Administration's (FDA) Draft Guidance "ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of DNA Origin." Docket No. FDA-2017-D-5767.