FDA Announces More Compounding Pharmacy Recalls
FDA inspections reveal possible inaccurate sterility testing.
FDA inspections of compounding pharmacies have revealed that results of some sterility testing by third-party laboratories may be inaccurate, causing potential risk to patients. University Compounding Pharmacy is voluntarily recalling products, including Testosterone Cypionate (Sesame Oil), Testosterone Cypionate/Testosterone Proprionate, and PGE-1 NS, for injection, to the consumer level. The recall is a result of FDA inspections of methods used by an independent third-party laboratory to assess sterility. FDA believes the sterility test results may not be reliable and there may be microbial contamination in products intended to be sterile.
Last week, FDA announced a voluntary recall of products from Medaus Pharmacy, including sterile compounded consumer products, due to inability to confirm that the quality control testing performed by an independent, third-party laboratory was conducted in a manner consistent with standards.
Source: FDA.gov
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.
