HHS regulations

FDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list used by outsourcing facilities for compounding.

HHS maintains a current list of certified laboratories and testing facilities authorized to conduct urine and oral fluid drug testing for federal workplace drug testing programs under the Mandatory Guidelines.

Centers for Medicare & Medicaid Services seeks public comment on proposed information collection activities under the Paperwork Reduction Act; interested parties may submit feedback on burden estimates and collection methods.

FDA requests public input on obesity's effects on drug pharmacokinetics and pharmacodynamics during development to inform safety, effectiveness, and dosing guidance for obese patients.

FDA classifies phototherapy devices for reducing acute post-surgical incision appearance as Class II medical devices, subject to special controls to ensure safety and effectiveness.

Center for Scientific Review holds closed meetings to review and discuss NIH grant applications and funding decisions affecting small research businesses and academic institutions.

FDA establishes public docket to collect examples of how patient-focused drug development meetings have influenced drug development efforts, community engagement, research priorities, and advocacy strategies.

Medicare announces a public meeting to receive comments on payment amounts for new and revised laboratory test codes under the Clinical Laboratory Fee Schedule for calendar year 2027.

National Institutes of Health Director's office will hold a public meeting to discuss agency priorities and research funding strategies.

Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests is rechartered with five new members and will hold public meetings July 14-15, 2026 to advise HHS and CMS on diagnostic laboratory test issues.

FDA classifies brain temperature measurement systems as Class II medical devices with special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

FDA seeks 60 days of public comment on information collection requirements for Good Laboratory Practice standards in nonclinical laboratory studies.

FDA classifies the laser-powered inferior vena cava filter retrieval catheter as a Class II medical device, requiring special controls to ensure safety and effectiveness for cardiovascular applications.

National Institutes of Health submits application to OMB for approval of information collection on clinical research training impact; 30-day public comment period open.

CMS seeks public comment for 60 days on proposed information collection activities under the Paperwork Reduction Act, inviting feedback on burden estimates and collection methodology.