Search results for: pharmaceuticals for children act

Best Pharmaceuticals for Children Act (BPCA) Pediatric Trials Network (PTN)

Although the primary focus of this Contract is to support the Best Pharmaceuticals for Children Act-Pediatric Trials Network clinical activities, NICHD also anticipates the need to utilize this Contract to acquire similar types of support for other NICHD pediatric drug development activities.BPCA 2017 authorizes NICHD to identify therapeutic gaps in pediatrics, which are pediatric diseases, disorders or conditions where more complete knowledge and

for the pediatric clinical trials, and select preclinical data conducted under the authority of the Best Pharmaceuticals for Children Act (BPCA).

Access to these data also increase the FDA’s ability to request regulatory impact studies such as those authorized under Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) to better understand the usefulness of drug labeling to clinicians. This can be done by examining actual use of products in hospitals in relation to recommended labeling.

(MIS-C) Data Platform Pilot project – COVID-19 Related Action that is currently being performed under the Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC) existing contract with EMMES Corporation, Inc., Rockville, MD.The EMMES Company, LLC currently serves as the DCC for the BPCA Clinical program and provides data coordinating and management services in support of ongoing BPCA Phase 1-3 pediatric clinical trial activities

Header InformationBid Number: S153412-vCurrent Description: Specialty Pharmaceuticals Bid Opening Date: 06/30/2024 12:00:00 PM Purchaser: Mary Beth Curley Organization: Department of Public Health Department: 1031CONVD - Default Data Conversion Department Location: 1031L - Default Data Conversion Location Fiscal Year: 13 Type Code: NS - Non-Statewide Solicitation Allow Electronic Quote: No Alternate Id: 306624 Required Date: Available Date : 05/

Converted bid item. See attachment section for complete bid information.