Topic
clinical trials
374 published works
Drug & Device Law
FDA’s Draft Guidance on Demonstrating Substantial Evidence of Effectiveness
By Lisa Baird
These days, even the ordinary lay press writes a fair amount about what is, and is not, good science. You would have to have a worm in your brain to…
Agricultural Law & Rural Practice | Solo Small Firm & General Practice Section
NIH Seeks Comments on Proposed Policy for Distributing Clinical Research Results to Participants
By Hall Render
On August 27, 2026, the National Institutes of Health (“NIH”) issued a Request for Information seeking public comment on its proposed NIH Policy on Sharing Summary Level Study Results with…
Duane Morris Life Sciences Law
FDA Launches IND Pilot Program
By Frederick R. Ball, Coleen W. Hill and Kelechi AnyatonwuThe U.S. Food and Drug Administration (FDA) recently announced the final design of its much-anticipated Expedited Investigational New Drug Pilot Program. To participate…
Arnold & Porter: News & Perspectives
Root Causes: Updates and Insights on Quality and Inspections
We are happy to launch a new newsletter, Root Causes: Updates and Insights on Quality and Inspections. The newsletter, which will come out roughly monthly, will discuss new developments in…
HLC - All Publications
FDA signals more inspections, scrutiny of clinical trials outside the U.S.
By Cadwalader Wickersham & Taft
Michael Davis and Karim Mikhail, named last week as permanent directors of the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and the Center for…
Agricultural Law & Rural Practice | Solo Small Firm & General Practice Section
Innovation, Ownership and Opportunity: Why Commercialization Begins During Clinical Research, Not After
By Hall Render
Why Commercialization Readiness Should Come Before Spending Development DollarsThe greatest legal risks in commercialization often arise before anyone uses the word “commercialization.” Long before an innovation or research asset is…
GoodLifeSci
UK Looks To Modernize Medicines And Medical Device Regulation In The Era Of AI
By Dr. Chris Boyle, Zina Chatzidimitriadou
A landmark program designed to deepen the regulatory partnership between the UK and the U.S., a regulatory ‘sandbox’ for AI as a medical device, evidence-gathering on AI regulation in healthcare,…
Australian Emergency Law
Paramedics and research on emergency care
By M. Eburn
Today’s correspondent asks: Can Paramedics and or Emergency First Responders randomly select and conduct “Phase 0,1,2,3 or 4 Medical Research Clinical trials” on patients (humans) under the Guardianship and Administration…
Life Sciences Perspectives
Deadline Approaching: OIG Seeks Input on Anti-Kickback Safe Harbors for Clinical Trial Participant Remuneration
On June 24, 2026, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued a Request for Information (“RFI”) seeking stakeholder input on payments…
Big Molecule Watch
FDA Revises Draft Guidance on Substantial Evidence of Effectiveness to Clarify Confirmatory Evidence Requirements for a Single Clinical Investigation
On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” …