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15

Apr

Ask and Ye Shall Receive, But Don’t Ask FDA for a Virtual Inspection

For more than a year we have been asking FDA to initiate virtual or remote inspections of drug manufacturing facilities.  FDA has conducted only a handful of on-site inspections – and no virtual inspections – of drug manufacturing facilities since the COVID epidemic shut down foreign travel 13 months ago.  FDA’s failure to perform inspections of foreign drug manufacturing facilities made it impossible for many companies to close out Warning Letters, climb off the Import Alert list, or secure approvals of drug applications delayed because FDA insisted on an on-site inspection...[FDALawBlog]

06

Mag

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

Mag

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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