On Dec 12, 2018, FDA issued a new proposal to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition Act of 2009 (BPCI Act). The BPCI Act amended the definition of biological product to include a “protein (except any chemically synthesized polypeptide.” To clarify these terms, FDA is proposing to provide its interpretation of the terms “protein” and “chemically synthesized polypeptide" to reduce regulatory uncertainty over what products are regulated as drugs or biological products.
AMCP webinar that discussed the midterm elections, the party split for the 116th Congress, and what may or may not come up as health care priorities for federal and state legislators.
Press Release: The Journal of Managed Care & Specialty Pharmacy (JMCP) is pleased to announce the addition of two experienced managed care pharmacy experts to the JMCP editorial team.