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The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. Indeed, FDA was forced to accelerate its work to advance regulatory convergence with trusted foreign regulatory partners by sharing information to complete inspectional activities, to advance certain medical product applications through the review process, and to help mitigate potential drug shortages. FDA’s “Resiliency Roadmap for FDA Inspectional Oversight” issued this month, summarizes the agency’s use of alternative inspectional tools and priorities going forward, calling the work to further leverage information shared through mutual recognition agreements (MRAs) “increasingly vital.” For example, FDA assessed expanding the use of MRA beyond in-country inspections to include third-country inspec
No need for jab to be approved by WHO, says FDA
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published : 13 May 2021 at 08:06
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The Food and Drug Administration (FDA) has confirmed that each country has the right to register Covid-19 vaccines that will be used by their people without relying on a vaccine list approved by World Health Organisation (WHO).
Secretary-General of the FDA Paisarn Dunkum said Covid-19 vaccines approved according to the WHO Emergency Use Listing Procedure (EUL) are for use under the Covax initiative. The procedure can also be used as a reference when considering Covid-19 vaccine registration in countries with an incomplete vaccine regulatory system, he said.
Vietnam s first high-potency zone opens in Binh Duong vir.com.vn - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from vir.com.vn Daily Mail and Mail on Sunday newspapers.