Resources
Implications of FDA’s New Rule on Laboratory-Developed Tests (LDTs) for Clinical Laboratories
On April 29, 2024, FDA introduced a significant regulatory shift affecting the landscape of diagnostic testing: the new rule governing Laboratory-Developed Tests (LDTs). Unlike commercially available tests that are subject to premarket approval by the FDA, LDTs were...
Breaking Down Risk Evaluation and Mitigation Strategies (REMS)
What is REMS? A pivotal role of the FDA is to protect public health by ensuring the safety and efficacy of drug products. In this pursuit, one of the key tools used by the Agency is the Risk Evaluation and Mitigation Strategies (REMS) program, established in 2007...
Snowball Sampling: Is it ethical to pay your study subjects to recruit participants on your behalf?
When new participants are recruited by current participants to become part of a study sample, it is called “snowball sampling.” This is a non-probability sampling technique that can be a practical way to identify and recruit individuals with certain characteristics to...