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FDA Focusing On Drug Shortage Risks From Puerto Rico Hurricane

 
• By Bowman Cox

FDA has identified more than 40 high-priority drug products from at least five companies and is offering assistance to resume operations, including 'coordinating transport of certain critical drugs out of Puerto Rico.'

Federal delegation arrives in Puerto Rico
Federal delegation arrives in Puerto Rico

The sun had not yet risen on the ninth day after Hurricane Maria struck Puerto Rico and took out the island's electrical grid when FDA Commissioner Scott Gottlieb boarded an Air Force jet at Andrews Air Force Base as part of a delegation of high-level federal officials.

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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

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More from Compliance

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

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UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 
• By Andrew McConaghie

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.