Podcast on Clinical Trial Challenges and FDA Solutions
A recent episode of the Business of Biotech podcast series features Allan Shaw. This installment highlights some of the major problems arising [...]
Robert Califf’s Ties to Big Tech Bring Scrutiny
Could Robert Califf lead the Food and Drug Administration (FDA)? Not until he explains his ties to technology companies. It’s [...]
Aetion Publishes 2021 eBook Showcasing RWE in Successful FDA Submissions
Aetion has published an eBook following an investigation into when and how real world evidence (RWE) successfully supports submissions to [...]
FDA Directors Discuss EUAs, Transparency, and COVID-19
In a recent meeting, Food and Drug Administration directors discussed how emergency use authorizations (EUAs) affected the response to the [...]
Why Did Medicare Squander $600 Million on Efficacy-Free Cancer Drugs?
According to a new JAMA report, Medicare spent almost $600 million in three years on drugs used in oncology treatments. [...]
FDA Releases Draft Guidance on RWD in Pharma Submissions
The Food and Drug Administration (FDA) has released its draft guidance on real world data (RWD). The guidance is intended [...]
ISPOR Seeks Comments for FDA Guidance on RWD
The International Society for Pharmacoeconomics and Outcomes (ISPOR) is seeking comments for a draft guidance document published by the Food and [...]
Aetion eBook Highlights the Impact of RWE in Successful Drug Approvals Ahead of FDA Framework
Aetion has published an eBook detailing how real world data (RWD) and real world evidence (RWE) can impact drug approvals [...]
Prescription Drug Pricing Reform Could Mean Discounts on AAP Drugs Pending Clinical Proof
As multidisciplinary stakeholders consider how to reform the prescription drug pricing structure, one recent proposal is gaining traction. Drugs pushed [...]
Interview With RWE Expert on Expectations for FDA Framework
In a recent interview with The Evidence Base, real world evidence (RWE) expert Sreeram Ramagopalan shared his thoughts on the [...]
RWE Expert Discusses Ripple Effects of FDA Framework Throughout Pharma
In a recent interview, Roche’s Global Head of Real World Evidence (RWE) and Market Access Sreeram Ramagopalan shared his thoughts [...]
ICER Whitepaper Proposes Improvements to the FDA’s Accelerated Approval Pathway
The Institute for Clinical and Economic Review (ICER) has released a whitepaper proposing policy reforms that would improve the Food and Drug [...]
FDA Launches Rare Disease Cures Accelerator-Data and Analytics Platform
Funded by the Food and Drug Administration, the Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) has just been launched. [...]
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. [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
Aetion Updates FDA Decision Alerts Database Following FDA’s Accelerated Approval of Oncology Drug LUMAKRAS
LUMAKRAS (sotarasib) was received accelerated approval from the Food and Drug Administration (FDA). The use of real world evidence (RWE) [...]
Aetion Adds Rabies Drug to FDA Decision Alerts Library Following Pediatric RWE Study
The Food and Drug Administration’s Center for Biologics Evaluation and Research has issued approval for a supplemental Biologics License Application [...]
ICER President Discusses How Iffy Biogen Decision May Bring Down FDA’s Accelerated Approval Program
Steve Pearson of the Institute for Clinical and Economic Review (ICER) weighed in on how the Food and Drug Administration’s [...]