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What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections

 
• By Bowman Cox

Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.

glass half full or empty?
experts take glass-half-full approach to interpreting guidance • Source: Shutterstock

Experts say industry should use the opportunity provided in recent guidance to volunteer information for the US Food and Drug Administration to use in lieu of site inspections it cannot conduct due to the coronavirus pandemic.

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US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

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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African Medicines Agency Set To Launch With New Leader In April

 
• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

China Plans Clinical Data Protection By Product Category For First Time

 
• By Xu Hu

After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
• By Sue Sutter

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.