In the late 1950s, a sedative marketed as safe for pregnant women left a trail of devastation: over 10,000 children born with severe limb deformities, organ damage, and other life-threatening birth defects.
Thalidomide became the defining pharmaceutical catastrophe of the twentieth century. Six decades later, that same molecule and its chemical descendants are saving lives as frontline treatments for multiple myeloma, a blood cancer that strikes an estimated 188,000 people worldwide each year.
| 1 | Celgene REMS programs are FDA-mandated safety systems controlling how REVLIMID (lenalidomide), POMALYST (pomalidomide), and THALOMID (thalidomide) are prescribed, dispensed, and monitored across the United States. |
| 2 | The core mission is preventing embryo-fetal exposure to known teratogens that caused over 10,000 birth defects during the thalidomide disaster of the late 1950s and 1960s. |
| 3 | Prescribers, pharmacies, and patients must each complete certification or enrollment before these medications can be prescribed, dispensed, or received. |
| 4 | Patients of reproductive potential must undergo pregnancy testing every four weeks and use two simultaneous forms of contraception throughout treatment. |
| 5 | Bristol Myers Squibb (which acquired Celgene for $74 billion in 2019) now administers these programs, and generic lenalidomide manufacturers must maintain identical REMS controls. |
| 6 | The FDA is modernizing REMS through digital integration with EHR systems and HL7 FHIR standards, with real-world pilots planned for 2026. |
| 7 | Non-compliance carries enforceable consequences: prescriber and pharmacy decertification, patient removal from the program, and potential FDA enforcement action against manufacturers. |
The system that makes this possible, that allows known teratogens to remain on pharmacy shelves while preventing a repeat of the thalidomide disaster, is called Celgene REMS.
Celgene REMS stands for Risk Evaluation and Mitigation Strategy, an FDA-mandated safety architecture governing how three high-risk medications manufactured by Celgene Corporation (now a subsidiary of Bristol Myers Squibb) are prescribed, dispensed, and used.
These programs represent some of the most rigorous risk management processes in pharmaceutical regulation, with interlocking controls across prescribers, pharmacies, and patients that no other drug class matches in complexity.
Three drugs fall under Celgene REMS: REVLIMID (lenalidomide), POMALYST (pomalidomide), and THALOMID (thalidomide). Each drug has its own dedicated REMS program with specific requirements, but the core safety architecture is shared.
As of 2025, REVLIMID alone generated $5.8 billion in annual revenue for BMS, even as generic competition erodes its market share. The financial stakes are massive, but the safety stakes are existential.
Why the FDA Requires REMS for These Medications
The FDA Amendments Act of 2007 (FDAAA) granted the agency authority to require REMS as a condition of drug approval or continued marketing. Standard safety measures like package inserts and medication guides work for most drugs.
They do not work when a drug causes irreversible harm that standard physician judgment alone cannot prevent. As of May 2025, the FDA maintains 77 active REMS programs, with 71 requiring Elements to Assure Safe Use (ETASU), the most restrictive tier of REMS controls.
Figure 1: The number of active FDA REMS programs has fluctuated as new drugs enter the market and older REMS are consolidated or eliminated. Source: FDA REMS Database; ACCME (2025).
The Celgene REMS programs sit at the top of this complexity hierarchy. The thalidomide disaster, which caused an estimated 10,000 to 20,000 embryo-fetal injuries with a roughly 40% mortality rate, directly shaped today’s strict regulatory framework.
Every element of these programs, from dual contraception requirements to monthly pregnancy testing to restricted pharmacy distribution, traces back to lessons learned from that catastrophe. Understanding the broader principles of risk assessment helps frame why the FDA treats these drugs differently from virtually everything else it approves.
The FDA mandates REMS when one or more of these conditions applies: the drug causes serious adverse events that labeling alone cannot prevent; the medication requires restricted distribution to avoid misuse or harm; healthcare providers need specialized training before prescribing; or patient comprehension of risks must be verified and documented on an ongoing basis. The Celgene REMS drugs trigger all four conditions simultaneously.
The Three Drugs Under Celgene REMS
Each of the three drugs covered by Celgene REMS treats serious, often life-threatening conditions. The clinical benefits are substantial, which is precisely why the FDA approves their continued use despite the teratogenic risks. Multiple myeloma alone accounts for 188,000 new cases and 121,000 deaths globally each year, making effective treatment options essential.
| Drug (Brand) | Active Ingredient | Primary Indications | Key Safety Risks |
| REVLIMID | Lenalidomide | Multiple myeloma, mantle cell lymphoma, myelodysplastic syndromes | Embryo-fetal toxicity, venous/arterial thromboembolism, neutropenia |
| POMALYST | Pomalidomide | Multiple myeloma (after prior therapies) | Embryo-fetal toxicity, venous thromboembolism, neutropenia |
| THALOMID | Thalidomide | Multiple myeloma, erythema nodosum leprosum (ENL) | Embryo-fetal toxicity, peripheral neuropathy, venous thromboembolism |
Generic versions of lenalidomide entered the U.S. market in 2022, seventeen years after the original FDA approval.
A critical point for compliance risk assessment: REMS obligations do not disappear when patent protection expires. Any generic manufacturer must either join a shared REMS system with the brand-name manufacturer or implement an equivalent standalone REMS. The safety architecture stays intact regardless of who supplies the medication.
Figure 2: REVLIMID revenue decline since generic lenalidomide entered the market in 2022. BMS has moved REVLIMID to its Legacy Portfolio. Source: Bristol Myers Squibb Annual Reports (2020-2025).
Why These Drugs Matter: The Multiple Myeloma Burden
The clinical context explains why the FDA tolerates the regulatory complexity of Celgene REMS rather than simply pulling these drugs from the market.
Multiple myeloma is the second most common hematological malignancy, accounting for 10-15% of all blood cancers.
Globally, an estimated 188,000 new cases and 121,000 deaths were recorded in 2022, with the burden expected to continue rising through 2045 as populations age.
Figure 3: Multiple myeloma incidence by region. Eastern Asia and North America together account for 40% of all new cases. Source: GLOBOCAN 2022; JNCI.
Lenalidomide-based regimens have become the backbone of first-line and maintenance therapy for multiple myeloma. Without REMS enabling safe access to these drugs, treatment options would shrink dramatically for hundreds of thousands of patients.
The risk appetite calculation here is stark: the FDA accepts the administrative burden of REMS because the alternative, losing access to first-line cancer therapies, is far worse.
How Celgene REMS Works: The Four Interlocking Pillars
The Celgene REMS programs are built on four interlocking pillars, each designed to close a specific gap in the safety chain. Remove any one pillar, and the entire framework weakens.
This layered control architecture mirrors the three lines model used in enterprise risk management: prescribers serve as the first line, pharmacies as the second, and the REMS system itself (with FDA oversight) as the third.
Figure 4: Distribution of compliance responsibilities across the four stakeholder groups in the Celgene REMS architecture. Source: Risk Publishing analysis (2026).
Pillar 1: Prescriber Certification
Every physician who intends to prescribe REVLIMID, POMALYST, or THALOMID must first become certified through the relevant REMS portal.
Certification requires the prescriber to review and understand the drug’s teratogenic risks, agree to counsel patients on contraception and pregnancy testing schedules, commit to enrolling patients before writing prescriptions, and re-certify periodically. This is not a checkbox exercise. Prescribers take on personal accountability for every patient they enroll.
Pillar 2: Pharmacy Certification
Pharmacies must also complete certification before dispensing these medications. Certified pharmacies agree to verify REMS authorization numbers before filling prescriptions, report inventory to BMS on a quarterly basis (electronic reporting in Q1/Q3, physical counts in Q2/Q4), and restrict dispensing to enrolled patients with valid authorization.
The operational risk management implications are significant: a pharmacy that dispenses without valid authorization faces decertification and FDA enforcement action.
Pillar 3: Patient Enrollment and Education
Patients cannot self-enroll. A certified prescriber must enroll each patient into the appropriate REMS program. Before enrollment, patients receive education covering the risk of severe birth defects, the absolute necessity of contraception, the prohibition on sharing medication, and requirements around blood and sperm donation restrictions.
Research on REMS effectiveness shows that 73,645 patients enrolled in the lenalidomide and thalidomide REMS programs demonstrated compliance with birth control requirements above 90% at treatment initiation and follow-up.
Pillar 4: Ongoing Monitoring and Surveys
The REMS program does not end at enrollment. Patients must complete monthly surveys confirming they understand the safety rules.
Patients who can become pregnant must undergo pregnancy testing every four weeks, with authorization numbers valid only seven days from the test date. All other patients receive 30-day authorization windows.
This continuous monitoring loop is the mechanism that separates REMS from standard drug safety measures and makes it one of the most robust risk monitoring systems in pharmaceutical regulation.
REMS Requirements at a Glance
| REMS Element | Prescriber | Pharmacy | Patient |
| Certification | Yes, with periodic renewal | Yes, with inventory reporting | N/A (enrollment required) |
| Education/Counseling | Must counsel on risks | Must verify authorization | Must confirm understanding |
| Pregnancy Testing | Must order per schedule | Must verify test date | Every 4 weeks (if applicable) |
| Monthly Surveys | N/A | N/A | Required before each refill |
| Authorization Window | Issues authorization | Verifies validity | 7 days (reproductive potential) / 30 days (others) |
| Inventory Reporting | N/A | Quarterly (electronic Q1/Q3, physical Q2/Q4) | N/A |
The Safety Chain: How Celgene REMS Prevents Embryo-Fetal Exposure
The central mission of every Celgene REMS program is preventing fetal exposure to teratogenic drugs. The system uses multiple redundant safeguards because no single control is sufficient on its own.
As practitioners of enterprise risk management, we recognize this as a defense-in-depth strategy: if one layer fails, the next catches the breach.
Contraception Requirements
Patients of reproductive potential must use two forms of contraception simultaneously: one highly effective method (such as an IUD, hormonal implant, or tubal ligation) plus one additional effective method (such as a latex condom or diaphragm).
True abstinence is accepted as an alternative only when consistent with the patient’s usual lifestyle. Male patients must also use latex or synthetic condoms during any sexual contact with females of reproductive potential throughout treatment and for four weeks after discontinuation, even after vasectomy.
Pregnancy Testing Schedule
| Timing | Test Requirement | Authorization Impact |
| Before starting treatment | Two negative pregnancy tests (sensitivity ≥50 mIU/mL) | Cannot begin therapy without confirmed negatives |
| During treatment | Every 4 weeks (every 2 weeks if irregular cycle) | Authorization valid 7 days from test date |
| End of treatment | Within 4 weeks of discontinuation | Confirms no exposure occurred |
Blood and Tissue Donation Restrictions
Patients must not donate blood during treatment and must wait a specified period after discontinuation. Male patients must not donate sperm.
These restrictions prevent indirect fetal exposure through donated biological materials, closing a risk pathway that would otherwise bypass the direct contraception controls.
Bristol Myers Squibb: Maintaining REMS Through Corporate Restructuring
Bristol Myers Squibb completed its acquisition of Celgene Corporation in November 2019 in a landmark $74 billion deal that created one of the world’s largest biopharma companies.
Since the acquisition, BMS has assumed responsibility as the REMS program administrator while maintaining the existing Celgene Risk Management portal infrastructure. Celgene shareholders received 1.0 BMS share plus $50 in cash per share, along with a tradeable Contingent Value Right tied to future regulatory milestones.
The transition has been operationally seamless. Prescribers, pharmacies, and patients continue using the same portals, certification processes, and authorization workflows. Understanding how organizations manage risk during major transitions is a core discipline in enterprise risk management frameworks.
The BMS-Celgene integration demonstrates how regulatory obligations transfer and must be maintained throughout corporate restructuring, a lesson that applies far beyond pharmaceuticals.
BMS has since moved REVLIMID to its “Legacy Portfolio” as generic competition accelerates. Revenue declined from $12.8 billion in 2021 to $5.8 billion in 2024, with H1 2025 showing a further 41% year-over-year decline.
The REMS obligations, however, do not decline with revenue. They remain fully binding regardless of the drug’s commercial trajectory.
The Other Side of Safety: Patient Burden and Access Barriers
REMS programs carry a tension that risk professionals understand well: controls designed to prevent harm can themselves create harm by delaying or blocking access to treatment.
Research consistently shows that REMS requirements can be burdensome for prescribers, pharmacists, and patients, with completion occurring outside standard clinical workflows at significant time and cost.
Patients report feeling reassured about drug safety through the REMS process, but many express difficulty understanding educational materials and navigating access requirements.
Prescribers carry an outsized burden: on top of patient care, they must obtain certification, complete ongoing education, enroll patients, ensure monitoring orders are placed, and verify safe-use conditions are met. Pharmacies operating in rural or underserved areas face particular challenges maintaining REMS certification when patient volume for these medications is low.
The FDA has acknowledged these concerns. In 2024-2025, the agency took several actions signaling a shift toward reducing REMS burden where safety data supports it: eliminating REMS for CAR T-cell therapies (June 2025), removing the clozapine REMS (February 2025), and dropping embryo-fetal toxicity REMS requirements for endothelin receptor antagonists (April 2025).
The Celgene REMS programs, however, remain fully intact. The teratogenic risks of thalidomide analogues, unlike the risks managed by eliminated REMS, have no margin for error. This distinction matters when evaluating risk tolerance thresholds.
What Separates Celgene REMS from Standard Drug Safety
Not all drugs require REMS. Most medications rely on standard safety measures: package inserts, medication guides, and post-marketing surveillance through MedWatch.
Celgene REMS represents a fundamentally different level of control, and the comparison illustrates why a risk assessment matrix is essential for calibrating controls to actual risk severity.
| Safety Feature | Standard Drug Safety | Celgene REMS |
| Prescriber Requirements | Prescribing information in package insert | Mandatory certification with educational module and periodic renewal |
| Pharmacy Requirements | Standard dispensing protocols | Certification, authorization verification, quarterly inventory reporting |
| Patient Requirements | Read medication guide | Enrollment, monthly surveys, pregnancy testing, dual contraception |
| Distribution | Open distribution through all licensed pharmacies | Restricted to certified pharmacies only |
| Monitoring | Voluntary adverse event reporting (MedWatch) | Mandatory monthly compliance data, authorization tracking, FDA assessments |
| Enforcement | Post-marketing surveillance | Active decertification, program removal, FDA enforcement actions |
Figure 5: Relative compliance burden of each Celgene REMS component, illustrating why pregnancy testing and patient enrollment carry the highest operational load. Source: Risk Publishing analysis (2026).
When the System Breaks: Consequences of Non-Compliance
Non-compliance with Celgene REMS carries tangible, enforceable consequences across every level of the safety chain.
Unlike many regulatory risk management frameworks where penalties are theoretical, REMS enforcement is active and immediate.
| Stakeholder | Non-Compliance Risk | Potential Consequence |
| Prescriber | Failure to verify pregnancy tests or complete enrollment | Decertification; inability to prescribe covered drugs |
| Pharmacy | Dispensing without valid authorization or missing inventory reports | Decertification; inability to dispense; FDA enforcement action |
| Patient | Failure to complete monthly surveys or pregnancy tests | Removal from program; loss of medication access |
| Manufacturer (BMS) | Failure to maintain REMS infrastructure | FDA warning letters; potential market withdrawal |
The FDA conducts periodic assessments of REMS program effectiveness and can require modifications when compliance data reveals gaps.
Building REMS compliance into standard operating procedures from day one, with dedicated REMS coordinators, automated authorization tracking, and monthly compliance audits, prevents the most common errors: dispensing on expired authorizations and missing inventory reports.
From Blueprint to Execution: A Phased Implementation Approach
Implementing Celgene REMS within a healthcare organization involves a structured sequence that mirrors the risk management lifecycle: identify requirements, implement controls, monitor compliance, and escalate when thresholds are breached.
| Step | Action | Details | Timeline |
| 1 | Prescriber Certification | Access REMS portal, complete educational module, submit certification agreement | 1-2 hours |
| 2 | Pharmacy Certification | Register through pharmacy portal, designate authorized representative, agree to inventory reporting | 1-3 business days |
| 3 | Patient Enrollment | Certified prescriber enrolls patient, provides education materials, documents acknowledgment | During first prescribing visit |
| 4 | Initial Pregnancy Testing | Two negative pregnancy tests (sensitivity ≥50 mIU/mL) | Before therapy begins |
| 5 | Authorization & Dispensing | REMS system generates authorization number; pharmacy verifies and dispenses | Same day as test confirmation |
| 6 | Monthly Compliance Cycle | Patient completes survey, undergoes pregnancy testing (if applicable), receives new authorization | Ongoing, monthly |
| 7 | Recertification & Training | Prescribers and pharmacies maintain active certification; staff training for new team members | Periodic, per REMS schedule |
The entire process, from prescriber certification to first dispensing, can be completed within one to two weeks when all parties act promptly.
The critical success factor is not speed but completeness: every step must be documented and verifiable, because the REMS system will reject any authorization request where prerequisites are missing.
Generic Competition and REMS: When Safety Obligations Outlast Patents
When generic versions of lenalidomide entered the market in 2022, a critical question was answered decisively: REMS requirements transfer to generic manufacturers in full.
The FDA requires that any generic version of a REMS-covered drug either join a shared REMS system with the brand-name manufacturer or implement an equivalent standalone REMS.
This dynamic creates unique challenges at the intersection of market access, intellectual property, and regulatory compliance.
REMS has been criticized as a potential barrier to generic entry: brand-name manufacturers control the shared REMS infrastructure, and some have historically used REMS sample restrictions to delay generic approvals by refusing to supply samples needed for bioequivalence testing.
The FDA Amendments Act addressed this partly, but the tension between safety controls and competitive access remains an active policy debate.
Generic lenalidomide manufacturers must meet the same prescriber certification, pharmacy certification, patient enrollment, and monitoring requirements as BMS.
The safety architecture does not change when the brand name does. For organizations managing third-party risk, this principle is instructive: compliance obligations follow the product, not the manufacturer.
The Digital Horizon: REMS Modernization and What Comes Next
The FDA is not standing still. The agency recognizes that REMS programs designed in the early 2000s were built for paper-based workflows that no longer reflect how healthcare operates. Several modernization initiatives are underway that will directly affect how Celgene REMS functions in the coming years.
Structured Product Labeling (SPL): The FDA now mandates that all REMS documents use the SPL format, making REMS requirements machine-readable. This standardization allows direct integration into electronic health records and pharmacy software, replacing manual portal lookups with automated compliance checks.
HL7 FHIR Integration: Working with MITRE Corporation and HL7, the FDA is developing open-source prototypes that use FHIR APIs to integrate REMS into prescriber and pharmacy workflows. The goal: prescribers and pharmacists complete REMS requirements without leaving their clinical systems. A real-world pilot is planned for early to mid-2026.
NCPDP SCRIPT Standards: Pharmacy data standards from the National Council for Prescription Drug Programs will enable automated authorization verification at the point of dispensing, reducing the manual steps that currently contribute to errors and delays.
These changes will not weaken Celgene REMS requirements. They will make compliance more efficient and less prone to the workflow interruptions that contribute to access delays.
For organizations tracking technology-driven risk management, the REMS integration initiative is a case study in how regulatory compliance evolves alongside digital health infrastructure.
Beyond Birth Defects: The Broader Patient Safety Mission
While preventing embryo-fetal exposure is the primary mission, Celgene REMS serves broader patient safety objectives that align with principles of operational resilience in healthcare settings.
Thromboembolism awareness. All three Celgene REMS drugs carry risk of venous and arterial blood clots. The REMS educational materials ensure prescribers and patients understand warning signs and preventive measures, including prophylactic anticoagulation when indicated.
Neutropenia monitoring. REVLIMID and POMALYST suppress white blood cell production. REMS-mandated education reinforces the need to report signs of infection promptly and to maintain regular blood count monitoring. These are key risk indicators in oncology care that directly correlate with patient outcomes.
Peripheral neuropathy screening. THALOMID causes irreversible nerve damage in some patients. The REMS program emphasizes early detection of symptoms, including tingling, numbness, or pain in extremities, so prescribers can adjust dosing before permanent damage occurs.
Informed decision-making. The enrollment process and monthly surveys ensure patients continuously understand the risks associated with their medication. This is not a one-time consent form; understanding is verified repeatedly throughout treatment. Effective patient safety programs share core principles with enterprise risk management frameworks: identify risks early, implement layered controls, monitor continuously, and escalate promptly when thresholds are breached.
Frequently Asked Questions
What does Celgene REMS stand for?
Celgene REMS stands for Risk Evaluation and Mitigation Strategy. These are FDA-mandated safety programs administered by Bristol Myers Squibb (formerly Celgene Corporation) that control how REVLIMID, POMALYST, and THALOMID are prescribed, dispensed, and used to prevent serious adverse events, particularly birth defects.
Which drugs are covered by Celgene REMS?
Three drugs and their generic equivalents: REVLIMID (lenalidomide), POMALYST (pomalidomide), and THALOMID (thalidomide). Generic lenalidomide, which entered the market in 2022, must comply with identical REMS requirements through a shared REMS system.
How long does REMS implementation take?
Prescriber certification can be completed in a single session (typically 1-2 hours). Pharmacy certification takes 1-3 business days due to inventory reporting setup. Patient enrollment happens at the first prescribing visit. The entire process from prescriber certification to first dispensing can be completed within one to two weeks.
What happens if someone does not comply?
Prescribers and pharmacies face decertification, preventing them from prescribing or dispensing covered drugs. Patients who fail to complete surveys or pregnancy tests lose authorization and cannot receive refills. The FDA can take enforcement action against manufacturers for systemic failures. Understanding risk treatment strategies helps frame why these consequences are calibrated to the severity of the risk.
Does Celgene REMS apply to all BMS medications?
No. Celgene REMS applies only to REVLIMID, POMALYST, THALOMID, and their generic equivalents. Other medications in the BMS portfolio are governed by standard FDA safety measures unless they have their own separate REMS requirements.
Can healthcare providers access patient data through Celgene REMS?
No. The REMS portals track certification, enrollment, authorization, and compliance data needed to administer the program. They do not share patient medical records or personal health information between providers. Each participant accesses only the data necessary to fulfill their specific REMS obligations.
Will the FDA ever eliminate the Celgene REMS programs?
Unlikely in the foreseeable future. While the FDA eliminated REMS for CAR T-cell therapies, clozapine, and endothelin receptor antagonists in 2024-2025, the teratogenic risks of thalidomide analogues remain absolute. There is no dose at which these drugs are safe for a developing fetus. The FDA’s risk assessment process for REMS modification requires evidence that safety can be maintained through less restrictive means, and for these drugs, that evidence does not exist.
Celgene REMS represents one of the most sophisticated applications of risk management in regulated industries. Whether you are a healthcare professional navigating compliance requirements or a risk practitioner studying how safety architectures translate across domains, the principles are universal: identify risks with precision, layer controls with redundancy, monitor with discipline, and enforce without exception.
For more on building robust risk management frameworks, explore our guides on risk assessment methodology, key risk indicators, and COSO ERM vs. ISO 31000.
References
[1] FDA, “Risk Evaluation and Mitigation Strategies (REMS),” https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems
[2] Bristol Myers Squibb, “Q4 & Full-Year 2024 Financial Results,” https://news.bms.com/news/details/2025/Bristol-Myers-Squibb-Reports-Fourth-Quarter-and-Full-Year-Financial-Results-for-2024/
[3] Vargesson, N. “Thalidomide-induced teratogenesis: History and mechanisms,” Birth Defects Research Part C (2015), https://pmc.ncbi.nlm.nih.gov/articles/PMC4737249/
[4] GLOBOCAN 2022, “Global Multiple Myeloma Incidence and Mortality,” JNCI (2024), https://academic.oup.com/jnci/article/117/5/907/7920408
[5] American Cancer Society, “Key Statistics for Multiple Myeloma,” https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html
[6] Lenalidomide REMS Portal, https://www.lenalidomiderems.com/
[7] THALOMID REMS Portal, https://www.thalomidrems.com/
[8] POMALYST REMS Portal, https://www.pomalysthcp.com/
[9] FDA, “REMS Integration Initiative,” https://www.fda.gov/industry/prescription-drug-user-fee-amendments/rems-integration-initiative
[10] Bristol Myers Squibb, “BMS Completes Acquisition of Celgene,” https://news.bms.com/news/details/2019/Bristol-Myers-Squibb-Completes-Acquisition-of-Celgene/
[11] Health Affairs, “Impact of REMS on Generic Approvals,” (2024), https://www.healthaffairs.org/doi/10.1377/hlthaff.2024.01476
[12] DIA Global Forum, “Evolving REMS for Complex Therapies,” (June 2025), https://globalforum.diaglobal.org/issue/june-2025/evolving-rems-for-complex-therapies-addressing-safety-in-innovation/
[13] ACCME, “FDA REMS Data,” https://accme.org/data-reporting/fda-rems/
[14] UBC, “Global Risk Management and REMS Developments 2024-2025,” https://ubc.com/insights/risk-management-rems-considerations-2025/
[15] MMS Holdings, “Enhancing Drug Safety with Digital Solutions in FDA REMS,” https://mmsholdings.com/perspectives/digital-solutions-in-rems/
Chris Ekai is a Risk Management expert with over 10 years of experience in the field. He has a Master’s(MSc) degree in Risk Management from University of Portsmouth and is a CPA and Finance professional. He currently works as a Content Manager at Risk Publishing, writing about Enterprise Risk Management, Business Continuity Management and Project Management.