Noted This Week

The FDA issued two draft guidances to support the approval of therapies for children—drugs, biological products, and vaccines—based on the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA), available at https://www.fda.gov/media/168201/download and https://www.fda.gov/media/168202/download. The documents "provide the agency’s current thinking about how industry can comply with PREA and BPCA, thus helping to increase the availability and timeliness of safe and effective medicines and vaccines for children" in the United States, said Lynne Yao, MD, director of the FDA’s Division of Pediatrics and Maternal Health. Comments on the draft documents can be made through July 17 at https://www.regulations.gov.

More Noted This Week, May 12–18   »