Data Packages, Inspections & Delayed Submissions: EMA Addresses Frequent Questions About Raw Data Pilot

Is it permissible to use data packages prepared for other international regulators? This is among the many questions the European Medicines Agency has addressed about its new pilot on analyzing raw data from clinical trials.

Close up.employees discuss financial data. photo with copy space
The EMA is exploring if analyzing raw data is beneficial • Source: Alamy

Drug companies taking part in a new pilot that the European Medicines Agency launched to assess whether the analysis of raw data from clinical trials can help it improve its medicines evaluation process might be able to use data packages prepared for other international regulators.

In addition, once companies have confirmed their intention to participate in the voluntary initiative, under which they must submit their...

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

More from Product Reviews

Stealth’s Forzinity Accelerated Approval Shows US FDA Confirmatory Trial Status Flexibility

 
• By 

Stealth has until March 2026 to begin enrolling its confirmatory trial for its Barth syndrome drug elamipretide, marking a rare instance where a novel drug received accelerated approval even though the required postmarketing study was not underway.

ACIP Weakened COVID-19 Vaccine Advice, But Less Than Rhetoric May Suggest

 

The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.

Inexperience And Confusion: ACIP Struggles To End MMRV, Hep B Debates

 

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

More from Pink Sheet

ACIP Weakened COVID-19 Vaccine Advice, But Less Than Rhetoric May Suggest

 

The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.

Inexperience And Confusion: ACIP Struggles To End MMRV, Hep B Debates

 

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.

US FDA Appears To Be Managing MAHA Well By Feeding Instead Of Receiving Priorities

 

The newly issued Make America Healthy Again strategy report suggests that FDA leaders are doing a good job of feeding ideas to the Trump Administration, rather than having the agency agenda dictated from above.