Related Experiment Video
Updated: May 24, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Current and future state of FDA-CMS parallel reviews
1Center for Medical Technology Policy, World Trade Center-Baltimore, Baltimore, Maryland, USA. donna.messner@cmtpnet.org
Abstract:
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) recently proposed a partial alignment of their respective review processes for new medical products. The proposed "parallel review" not only offers an opportunity for some products to reach the market with Medicare coverage more quickly but may also create new incentives for product developers to conduct studies designed to address simultaneously the information needs of regulators, payers, patients, and clinicians.
Related Concept Videos
FDA Approved Drugs: Changes to Approved Drugs
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Regulation
Clinical Trials: Overview
Drug Products: Biologics, Biosimilars and Interchangeables
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
