Related Experiment Video
Updated: Jun 25, 2025

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
United Kingdom Data Deficiencies Influencing U.S. FDA Decisions
Ingrid Skop1, Calum Miller2, Kevin Duffy3
1Vice President and Director of Medical Affairs, Charlotte Lozier Institute, 2800 Shirlington Rd, Arlington, Virginia 22206, United States.
None:
The U.S. FDA has permanently removed the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing prescribing through telemedicine or on-line ordering and distribution through the mail and pharmacies, without standard pre-abortion testing. This will increase the risk of complications due to failure to adequately determine the gestational age or rule out ectopic pregnancy by ultrasound or physical exam, failure to perform labs to document whether RhoGAM is indicated, and failure to obtain appropriate informed consent to prevent unwanted abortions, among other concerns. The FDA justified this action by referencing flawed studies with significantly undercounted complications. The details of these study deficiencies are examined in this paper.
More Related Videos
06:55Scanning Light Scattering Profiler SLPS Based Methodology to Quantitatively Evaluate Forward and Backward Light Scattering from Intraocular Lenses
Published on: June 6, 2017
06:55Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
Related Concept Videos
Drug Regulation
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 Control Governance: Regulatory Bodies and Their Impact
Clinical Trials: Overview
Drug Nomenclature
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...