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Hepatitis A vaccine shortage

Since 2017, large outbreaks of hepatitis A among adults have been occurring in a number of US cities and states, resulting in increased demand for vaccine. Initially, supplies of adult hepatitis A vaccine in the US were constrained.  In response, CDC took a number of steps to mitigate the supply issues.  Specifically, CDC (1) worked directly with public health officials in affected jurisdictions to provide guidance about targeting vaccine in response to local epidemiology; (2) collaborated with manufacturers to understand options for managing supplies in the private sector and increasing national supply; (3) implemented ordering controls in the public sector; and (4) increased vaccine availability on CDC’s adult vaccine contracts.

Nevertheless a shortage has formed in 2020-2021

Source: CDC

Daily Remedy

Daily Remedy

Dr. Jay K Joshi serves as the editor-in-chief of Daily Remedy. He is a serial entrepreneur and sought after thought-leader for matters related to healthcare innovation and medical jurisprudence. He has published articles on a variety of healthcare topics in both peer-reviewed journals and trade publications. His legal writings include amicus curiae briefs prepared for prominent federal healthcare cases.

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Policy Shift in Peptide Regulation

FDA Evaluation of Certain Bulk Drug Substances in Compounding: Clinical Interpretation

FDA Evaluation of Certain Bulk Drug Substances in Compounding: Clinical Interpretation

Clinicians increasingly encounter patients using or requesting peptide-based therapies sourced through compounding pharmacies. The U.S. Food and Drug Administration has identified a subset of bulk drug substances, including certain peptides, that may present significant safety risks when used in compounded formulations. The clinical question is whether these regulatory signals reflect meaningful patient-level risk and how they should influence prescribing behavior. This matters because compounded peptides often sit outside traditional approval pathways, creating uncertainty around quality, dosing consistency, and safety. Understanding...

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