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Changes in the country’s political landscape may affect the pharmaceutical industry market in the future.
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
The use of commercially available media to achieve high titer in early process development is discussed.
The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.
The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.
The agency releases five draft guidance documents related to drug compounding and repackaging.
Market forces may limit the success of CMOs.
FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.
Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.
The company voluntarily recalls product due to FDA observations of potential sterility problems.