Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients With Renal Impairment; Public Workshop

FDA Announced Public Workshop on ADEPT 8 Pediatric Renal Impairment - Drug Information Update https://www.federalregister.gov/documents/2023/09/26/2023-20903/advancing-the-development-of-pediatric-therapeutics-on-drug-dosing-in-pediatric-patients-with-renal?utm_medium=email&utm_source=govdelivery#:~:text=The%20main%20objective%20of%20the,and%20explore%20scientifically%20supported%20approaches FDA announced the public workshop “Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients with Renal Impairment.” The meeting will be held on Thursday, November 30 and Friday, December 1 from 9 a.m. to 5 p.m. ET. This workshop will be both on-site on the FDA’s White Oak Campus (Silver Spring, MD) and virtually.  The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge and consider innovative approaches to improve the current model for dosing. The workshop will allow time for open discussion and will specifically focus on measurements of renal function, extrapolation of adult data, and approaches to generating clinical trial data to assess the impact of renal impairment on the movement of drugs within the body in pediatric patients. All attendees must register. FDA announced the public workshop “Advancing the Development of Pediatric Therapeutics (ADEPT 8) on Drug Dosing in Pediatric Patients with Renal Impairment.” The meeting will be held on Thursday, November 30 and Friday, December 1 from 9 a.m. to 5 p.m. ET. This workshop will be both on-site on the FDA’s White Oak Campus (Silver Spring, MD) and virtually.  The purpose of the public workshop is to discuss the current landscape of drug dosing in pediatric patients with renal impairment, understand the gaps in knowledge and consider innovative approaches to improve the current model for dosing. The workshop will allow time for open discussion and will specifically focus on measurements of renal function, extrapolation of adult data, and approaches to generating clinical trial data to assess the impact of renal impairment on the movement of drugs within the body in pediatric patients. All attendees must register. https://www.eventbrite.com/e/adept-8-pediatric-renal-impairment-workshop-tickets-687423571407?utm_medium=email&utm_source=govdelivery