Category Archives: International Pharmaceutical Regulatory Monitor

FDA Releases Final Guidance on Chemical Drug Starting Materials

By | International Pharmaceutical Regulatory Monitor | No Comments

The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials.
Source: International Pharmaceutical Regulatory Monitor

EMA Issues Guidance on Biomarkers, Criteria for Alzheimer’s Medicines

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The EMA’s Committee for Medicinal Products for Human Use adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design and analysis of safety studies and the potential use of biomarkers in various stages of medicinal development.
Source: International Pharmaceutical Regulatory Monitor

FDA Issues New Guidance on Priority Review Vouchers

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Drug products seeking an FDA designation as a medical countermeasure — defined as products used to diagnose, prevent or treat conditions associated with chemical, biological, radiological and nuclear threats — must not be previously approved for another indication, the agency said, in a new draft guidance.
Source: International Pharmaceutical Regulatory Monitor