Search Results for continuous manufacturing

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Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Manufacturing

Tags: continuous manufacturing, Pfizer, AAM, Vertex, AstraZeneca

FDA Finalizes Guidance on Emerging Manufacturing Tech Program By Michael Mezher - Published 28 September 2017

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Manufacturing, Submission and registration

Tags: Emerging Technology, Continuous Manufacturing, Guidance

FDA Unveils Regulatory Science Progress Report By Zachary Brennan - Published 30 March 2017

The report, covering fiscal years 2015 and 2016, notes significant US Food and Drug Administration (FDA) progress in refining non-clinical and clinical tools to better evaluate medical products, advancing manufacturing and quality, and enhancing internal IT tools to support the scientific review of regulatory applications.

Categories: News, US, FDA, Biologics and biotechnology, Drugs

Tags: regulatory science, non-clinical models, biomarkers, continuous manufacturing

FDA Allows First Switch From Batch to Continuous Manufacturing for HIV Drug By Zachary Brennan - Published 12 April 2016

The US Food and Drug Administration (FDA) for the first time in its history allowed a manufacturer to switch from the more antiquated batch manufacturing process to a continuous manufacturing process – a move that FDA is seeking to encourage among more pharmaceutical manufacturers.

Categories: News, US, FDA, Compliance, Drugs, Due Diligence, Manufacturing, Quality

Tags: continuous manufacturing, Janssen, Prezista, Vertex, batch manufacturing