HHS Grants Liability Protection to Pandemic Vaccine Manufacturers
Manufacturers of vaccines used to prevent potential avian pandemics will receive immunity from product liability claims, HHS announced on January 1.
Manufacturers of vaccines used to prevent potential avian pandemics will receive immunity from product liability claims, HHS announced on January 1.
The move, which triggers a provision of the Public Readiness and Emergency Preparedness Act passed in late 2005, would grant protection from such claims for parties involved in the preparation of reference strains and the development, manufacturing, testing, and administration of vaccines.
The notice said that the liability was granted “to encourage the design, development, clinical testing or investigation” of countermeasures, based on the “credible risk” that that an avian influenza outbreak could spread to humans.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
