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March 16, 2021
Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
March 15, 2021
The agency’s focus appears to be on generic drugs for the upcoming year.
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
March 04, 2021
The agency is working to identify and obstruct scammers looking to profit from the pandemic.
The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.
March 02, 2021
The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.
Auditing distribution suppliers provides understanding and documentation of the services performed, says Siegfried Schmitt, vice president, Technical at Parexel.
March 01, 2021
To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health.