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Pfizer plans to submit data on a 4th Covid shot to FDA

Pfizer is close to submitting data to the Food and Drug Administration on a fourth dose of its Covid-19 vaccine, according to CEO Albert Bourla.

“Clearly there is a need in an environment of omicron to boost the immune response,” he told CNBC in an interview Friday.

Source: NBC News

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.

Videos

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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