FDA Creates Shared REMS System for TIRF Medicines
On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, a single-shared risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, narcotic pain medicines used by cancer patients to manage pain.
On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, a single-shared risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, narcotic pain medicines used by cancer patients to manage pain. The TIRF REMS program is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems.
“This TIRF REMS will ensure safe use and access to these drugs for patients who need them,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research in a press release. FDA hopes to limit the risk of misuse, overdose, abuse, and complications related to TIRF medicines, which include the brand names Abstral, Actiq, Fentora, Lazanda, and Onsolis. The program will ensure that TIRF drugs are prescribed and dispensed only to appropriate patients and will prevent inappropriate conversion between fentanyl products.
Prescribers, patients, and pharmacies will begin using the program beginning in March 2012, but until then the current individual REMS programs will continue to be used. Those already enrolled in established individual REMS for TIRF products will automatically be transitioned to the shared program. Patients who receive TIRF medicines in inpatient situations (e.g., hospitals and hospices) will not be required to enroll in the program, nor will the doctors that prescribe TIRF drugs in inpatient situations. However, patients receiving the medicines on an outpatient basis are required to be enrolled.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Kyron.bio Raises €5.5M to Advance Precision Glycan Engineering for Safer Antibody Therapeutics
May 28th 2025Funding will support the company’s efforts to refine its proprietary glycan-engineering platform, expand its scientific and operational team, and advance preclinical studies of its engineered biologics.
