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News from the world

09

Apr

Does the US Drug Shortage White Paper Fall Short?

The U.S. Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States—with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.  With the COVID-19 pandemic in the not-so-distant past, we trust that a recitation of the importance of a resilient supply chain is not needed here.  As noted in the White Paper and discussed in greater detail in the Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad Based Growth: 100-Day Reviews under Executive Order 14017, 52% of all FDA-registered finished dosage form manufacturing facilities and 73% of all FDA-registered API-manufacturing facilities were located outside the United States as of March 2021. For generic drug manufacturing facilities specifically, the numbers are 63% and 87%.,,,[FDABlog]

24

Apr

EMA Unveils Recommendations to Tackle Critical Medicine Shortages

Identifying and reducing production and delivery vulnerabilities are the focus of the European Medicines...

22

Apr

EMA Launches Medicine Shortages Monitoring Platform

To detect, prevent and manage medicine shortages in the EU and European Economic Area (EEA), the European...

22

Apr

WHO issues guidance on nitrosamine controls in drug manufacturing

The World Health Organization (WHO) released draft guidance for comment this month on good manufacturing...

16

Apr

FDA aims for greater use of remote assessments for low-risk facilities

The US Food and Drug Administration (FDA) has conducted more than 20 remote regulatory assessments (RRAs)...

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