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Advocates Press For US FDA Rare Disease Center Of Excellence

 
• By Derrick Gingery

Attorneys' proposal aims to better connect dispersed rare disease expertise within FDA's drug, biologic, and device centers through more leadership, new advisory committee.

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A proposal to create a rare disease center of excellence at the US FDA would allow closer collaboration between experts in the product centers, as well as add more dedicated leadership within the agency and access more expertise outside it.

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• By Francesca Bruce

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US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases

 
• By Sarah Karlin-Smith

Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

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How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.