by hormoneaccess | Dec 5, 2021 | Issue: FDA Ban of Compounded Hormones
Under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) – Protein-based drug products like hCG, FSH, and hMG that had been approved as “drugs” over 15 years ago are now considered “Biologics” and now fall under the jurisdiction of the FDA’s Center for...
by hormoneaccess | Dec 5, 2021 | Issue: FDA Ban of Compounded Hormones
For a quick video that describes this issue, click here: NASEM Report Finds Compounded HRT of No Clinical Benefit After the FDA directed the National Academies of Sciences, Engineering, and Medicine (“NASEM”) in 2018 to create a committee to assess the...
