1. Pink Sheet
  2. >>Conferences
  3. >>DIA

Anti-Globalism Policy Cannot Stifle International Cooperation, US FDA’s Califf Says

 
• By Derrick Gingery

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

international cooperation
Australia TGA official says regulators shouldn't look for logic in some political positions and remain focused on providing safe and effective medicines. • Source: Shutterstock

SAN DIEGO – The pharmaceutical industry likely will remain dependent on worldwide operations despite rising political opposition to globalization, US Food and Drug Administration Commissioner Robert Califf said, which necessitates continued coordination with foreign regulators.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from DIA

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By Sue Sutter

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

DTC Advertising: Industry Learning To Live With US FDA’s Clear, Conspicuous And Neutral Rule

 
• By Sue Sutter

Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.

CDER, CBER Report More Hiring Gains, But At Slower Rate Than Earlier In Fiscal Year

 
• By Derrick Gingery

Pink Sheet infographic shows that while overall growth continues at the drugs and biologics centers, the US FDA still must add many employees to meet user fee-mandated hiring goals.

Existing Innovative Trial Design, Endpoint Tools Could Be Help Ultra-Rare Sponsors Need

 
• By Derrick Gingery

Amid a push for new incentives, the US FDA’s Kerry Jo Lee, associate director for rare diseases in the Center for Drug Evaluation and Research’s Office of New Drugs, said in an interview with the Pink Sheet that the tools ultra-rare sponsors need already are available.

More from Conferences

US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 
• By Eliza Slawther

Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 
• By Eliza Slawther

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By Sue Sutter

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.