REMS Administrators

Pharmaceutical company responsible for LUMRYZ REMS implementation in the U.S., including prescriber and pharmacy certification and controlled distribution safeguards.

Biopharmaceutical company responsible for BRIXADI REMS implementation in the U.S., with certified provider and pharmacy requirements and controlled outpatient distribution pathways.

Pharmaceutical company responsible for the U.S. SUBLOCADE REMS program, including enrollment, certified healthcare setting controls, and controlled dispensing requirements.

Pharmaceutical sponsor operating SPRAVATO REMS restricted-distribution controls for supervised administration, site certification, and patient enrollment in the US market.

Biopharmaceutical company that administers the U.S. XYWAV and XYREM REMS restricted distribution program, including certification, dispensing controls, and program reporting requirements.

U.S. shared-system REMS program for transmucosal immediate-release fentanyl products, maintaining restricted prescriber, pharmacy, and patient enrollment controls.

US federal regulator with statutory authority to require and enforce Risk Evaluation and Mitigation Strategies (REMS) for drug products where additional safety controls are needed.

U.S. REMS program for isotretinoin products that enforces pregnancy-prevention controls through prescriber, pharmacy, and patient workflow requirements.