The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ISEMBYLD (apitegromab-mstn), approved Sep

Original title: “Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ISEMBYLD (apitegromab-mstn)”

The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) is requesting to move the Serious Medical Procedure Request (SMR) Form (Office of Management and Budget (OMB) #: 0970-0561, expiration December 31, 2026) under the Medical Assessment Form and Dental Assessment Form (OMB #: 0970-0466, expiration 10/31/ 2026) information collection and update the title of OMB # 0970-0466 to Office of Refugee Resettlement (ORR) Unaccompanied Alien Child Health Forms. Revisions a

Original title: “Submission for Office of Management and Budget Review; Office of Refugee Resettlement (ORR) Unaccompanied Alien Child Health Forms”

Following the withdrawal of billions of dollars in investments from Boehringer Ingelheim and Eli Lilly, German lawmakers have proposed a clause to the country’s healthcare reforms set to take effect Jan. 1.

Original title: “Roche flags ‘final opportunity’ for Germany to reestablish as a reliable investment location”

Read twice and referred to the Committee on the Judiciary.

Original title: “S 1837: Law Enforcement Training for Mental Health Crisis Response Act of 2021”

Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.

Original title: “HR 3595: Law Enforcement Training for Mental Health Crisis Response Act of 2021”

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Action Levels for Cadmium in Processed Food Intended for Babies and Young Children." The draft guidance, when finalized, will establish action levels for cadmium in certain processed foods intended for babies and young children less than 2 years old. The draft guidance is intended to set achievable action levels that will help further reduce cadmium in the food supp

Original title: “Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability”