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News dal mondo

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]

22

Apr

Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

he European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete...

20

Apr

US GDUFA III: Use MDUFA model to create competition in generic drug markets

To design an effective financing system for generic drug approvals, the FDA must balance the need...

20

Apr

Pharmaceutical reshoring: a strategic necessity

More than a year into the COVID-19 crisis, the novel coronavirus continues to disrupt our societies,...

19

Apr

Covid-19 ministro Speranza firma nuove Ordinanze per contenere la diffusione del virus

Il Ministro della Salute, Roberto Speranza, sulla base dei dati e delle indicazioni...

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