Funded by the Food and Drug Administration, the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) has just been launched. The resource is intended to accelerate rare disease research. Approved investigators will have access to deidentified patient-level data. “RDCA-DAP […]
NESTcc’s Active Surveillance Roadmap Open for Public Comments Until October
The National Evaluation System for health Technology (NESTcc) recently revealed its Active Surveillance Roadmap to collect secure de-identified real world data. It will hold a webinar on September 23rd regarding the approach and will take feedback before October 11th. “FDA tasked NESTcc with […]
HEOR Policy Experts Present Drug Pricing Reform Options, Discuss FDA’s Accelerated Approval Mechanism and Pricing Negotiation
Health economics and outcomes research (HEOR) experts at the USC-Brookings Schaeffer Initiative for Health Policy and the Washington University School of Law reveal a framework intended to guide discussions and policy on drug pricing reform. Their comprehensive framework details Medicare Part D […]
Can the FDA’s Humorous Social Media Posts Combat Scientific Misinformation?
The Food and Drug Administration (FDA) is incorporating humor into its social media messages aimed at reducing the spread of scientific misinformation. A recent Twitter post warning against ivermectin for use in COVID-19 drew thousands of likes and retweets. Experts think the use of humor could […]
Two Senior FDA Vaccine Leaders Exit Agency, Unnamed Official Points to Biden Administration Overstepping on COVID-19 Boosters
Two senior members of the Food and Drug Administration (FDA) are exiting the agency amid speculation that the Biden administration has failed to respect the FDA’s autonomy regarding COVID-19 vaccine boosters, among other issues. Marion Gruber and Phil Krause have made substantial contributions to […]
Aduhelm Approval Prompts Discussions on Reforming the FDA’s Accelerated Approval Pathway
The Food and Drug Administration (FDA)’s contentious approval of Biogen’s Aduhelm has prompted discussions on how the accelerated approval process could be reformed. The FDA’s Rick Pazdur expressed concern while a recent article co-authored by the Institute for Clinical and Economic Review (ICER)’s […]
Former FDA Officials Discuss the Far-Reaching Effects of RWD During the COVID-19 Pandemic
Amy Abernethy, former deputy principal commissioner at the Food and Drug Administration (FDA), discussed the impact of the COVID-19 pandemic on the use of real world data (RWD). Abernethy, along with two other former FDA officials, note the widespread use of RWD to speed up approval of novel […]
Should the FDA Follow Advisory Committee Votes in Drug Approvals?
A recent survey requested feedback from advisory committee members. Most respondents thought that a thumbs down from committee members should lead to the Food and Drug Administration (FDA) denying the drug. The FDA disagrees. “Nearly two-thirds of surveyed FDA AdComm members believe there should […]
Vanderbilt Scientist and Aetion RWE Strategist Highlight Seven Solutions to Bolster FDA’s Accelerated Approval Process and Achieve Value-Based Pricing
Aetion’s Dr. Nirosha Mahendraratnam Lederer and Vanderbilt’s Dr. Stacie B. Dusetzina discuss how value-based pricing may be achieved using the Food and Drug Administration’s accelerated approval pipeline. They propose seven recommendations that can address many of the problems facing the FDA, […]
95 Pharma-Backed Oncologists Support Woodcock for FDA Commissioner
Dr. Janet Woodcock has faced widespread criticism as news spread that she was being considered for Food and Drug Administration (FDA) Commissioner. It has now been revealed that some of her supporters received a substantial amount of pharma funding. Another potential contender, Dr. Ezekiel Emanuel, […]
