Topic
Drug Effectiveness
6 published works
Napoli Shkolnik Blog
All About the Sudafed Class Action Lawsuit
Following a Food and Drug Administration finding that the decongestant phenylephrine is no more effective than a placebo, a Minnesota consumer filed a class action lawsuit against Kenvue, Inc. and…
Of Digital Interest
FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness
By Vanessa K. Burrows, Michael W. Ryan, Jennifer S. Geetter
At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s…
Focus on Regulation
FDA Continues Efforts to Complete DESI Review For Certain Drug Products
By David Stein
As part of FDA’s continuing efforts to complete its Drug Efficacy Study Implementation (DESI) review, FDA published a July 24, 2012, Federal Register notice offering companies an opportunity to affirm…
Health Industry Washington Watch
OIG Report on Less-Than-Effective Drugs in the Medicare Part D Program
A new OIG report, "Review of Less-Than-Effective Drugs in the Medicare Part D Program," examines Medicare Part D coverage of drugs the FDA approved before 1962 but subsequently found to…
Health Industry Washington Watch
Summaries of Effectiveness and Safety
The FDA is announcing the availability of final guidance for industry entitled “Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document.” The guidance clarifies where within the…
Elder Law Prof Blog
CMS Administrator McClellan Proposes Using Medicare Drug Benefit Data To Track Medication Safety, Efficacy
According to the LA Times, Medicare head Mark McClellan, a doctor and an economist who once ranthe FDA, has proposed a Medicare-based system to track the safety andeffectiveness of medications.…