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The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
The authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Understanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
May 02, 2024
Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.
May 01, 2024
The new draft guidance from FDA provides recommendations for sponsor companies on cell safety testing of human-origin allogeneic cells.
April 30, 2024
Shanghai Henlius Biotech’s first biosimilar has previously received approvals by the European Commission and National Medical Products Administration.
April 26, 2024
Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy, helps adults with hemophilia B produce factor IX themselves instead of receiving regular intravenous infusions.
April 25, 2024
The approval, given across three indications, follows a previous approval for second-line use in esophageal squamous cell carcinoma.
April 24, 2024
GSK’s supplemental Biologics License Application for its PD-1-blocking antibody therapy has been accepted for review by FDA.
April 23, 2024
The BioMaP-Consortium includes members of the biopharmaceutical industry and supports BARDA.
April 22, 2024
BioPharm International sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies at INTERPHEX 2024 to examine the implementation of Annex 1.
At INTERPHEX 2024, a panel of experts gave insight on new regulatory requirements for contamination control and provided advice for how to implement a contamination control strategy in existing facilities.
The outcomes of a workshop organized by WHO and ICMRA regarding COVID-19 vaccine strain updates are presented in a report published by regulators.