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While innovators use standard surfactants, a 505(b)(2) applicant might use short peptides (di- or tri-peptides) that act as modular stabilizers and antioxidants
Phase II data showed that a 24mg dose of CT-388 enabled 54 percent of participants to attain resolution of obesity
February 12, 2024
The Essentially a Copy Conundrum At the very heart of the legal framework governing 503B facilities is a single, powerful prohibition: a compounded drug product cannot be essentially a copy of one or more approved drugs to qualify for the exemptions under Section 503B
This framework is outdated for people who want to protect their metabolic health rather than wait for it to deteriorate
The extent of this effect varies among different peptides and their related impurities
