FDA Says GMP Lapses In Facilities And Production Areas More Common For Cell And Gene Therapies
US FDA investigators are more likely to cite cell and gene therapy manufacturers for facilities and production deficiencies, agency says, while industry reports difficulties complying with drug GMP requirements that are not always applicable to cell and gene therapies.
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New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, including Sanofi's Sarclisa for treating adults with relapsed and refractory multiple myeloma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
Eyes On Pricing As Zolgensma Moves Closer To Japan Market
Government advisory committee gives initial nod to what will become Japan’s most expensive single drug, but reimbursement pricing could come in for close scrutiny.
US FDA CBER Chief Calls For Industry-Academia Collaboration In Developing Treatments For Ultra-Rare Diseases
The head of the US FDA’s Center for Biologics Evaluation and Research said that new approaches are needed to facilitate product development for ultra-rare diseases. The FDA also announces the creation of a new CBER Advanced Technologies Team to promote the adoption of innovative manufacturing technologies for cell and gene therapy products.