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News from the world

24

Feb

FDA Revises Nitrosamine Guidance to Extend Recommended Timeframe for Nitrosamine Risk Assessments to March 31, 2021

To ensure the safety of the U.S. drug supply, the guidance recommends that manufacturers should conclude the risk assessment of approved or marketed products, the first of three steps manufacturers should follow to mitigate nitrosamine impurities in their products, within 6 months of publication of the guidance. Through today’s revision to the guidance, FDA extends the recommended timeframe for completion of risk assessments to March 31, 2021.
Manufacturers do not need to submit risk assessment documents to the agency, but they should retain these documents so that they are available if requested....[FDA]

06

May

EDQM - New policy for the development of monographs on medicinal products containing chemically defined active substance salts or bases/acids

At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission approved a new...

05

May

EU Draft report on a pharmaceutical strategy for Europe

Draft report on a pharmaceutical strategy for Europe [2021/2013(INI) – Rev. 26 aprile...

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