Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.
Regulatory issues may wax and wane, but useful insights can surface along the way that may serve as guideposts for the regulated community.
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The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease
