Avoid Launch Delays By Planning For An FDA-Required REMS Risk

lt;p>Picture this: The FDA accepts a manufacturer&#39;s NDA, and the manufacturer plans for its impending launch. But shortly before the anticipated approval, the FDA notifies the manufacturer that a Risk Evaluation and Mitigation Strategy (REMS) program is required to market the product.&nbsp;Now what?</p>

REGULATORY AND OTHER PITFALLS IN DRUG DEVELOPMENT

Post-marketing authorisation safety and efficacy surveillance of advanced therapy medicinal products in Brazil, the European Union, the United States and Japan - Cytotherapy

Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling - ScienceDirect

Flawed safety rules limit a highly effective schizophrenia treatment - STAT

Food and Drug Administration (FDA) Risk Evaluation and Mitigation

conceptually similar components between Food and drug admin

When a REMS is Necessary: FDA Finalizes Guidance

REMS in Oncology

Risk Evaluation and Mitigation Strategy (REMS) Programs

FDA REMS Program REMS: Risk Evaluation & Management Strategy - ppt download

Responding to the opioid crisis in North America and beyond: recommendations of the Stanford–Lancet Commission - The Lancet

White Paper, Missed Opportunities When Developing a REMS Program