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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.

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NHC Comments on Key Information and Facilitating Understanding in Informed Consent

Putting Patients First Blog

Assessment of length and readability of informed consent documents for COVID-19 vaccine trials. Mayo Clinic Proceedings, 96(8) , 2095-2101. A blueprint for developing patient-centered core impact sets (PC-CIS). He is reachable via e-mail at egascho@nhcouncil.org. Sincerely, Randall L. and Boyle, C. and Argo, N.