Social Media Ideas for Clinical Trial Modernization Act

Nearly 200 Organizations Back Bill to Expand Access to Clinical Trials

Nearly 200 healthcare and patient advocacy organizations endorsed the bipartisan Clinical Trial Modernization Act, which seeks to reduce financial barriers and expand access to cli...

OIG Seeks Comment on Clinical Trial Participant Remuneration Under the AKS and Beneficiary Inducements CMP

On June 24, 2026, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published a Request for Information (“RFI”) seeking public in...

Clinical Trial Transparency Enforcement: A Practical Guide for Sponsors and Research Sites After FDA’s April 2026 Remind...

HHS proposes plan to speed up clinical trials

HHS Secretary Robert F. Kennedy Jr. wants to speed up clinical trials in the United States.“A recent study found that China conducts more early-stage clinical trials than the Unite...

<![CDATA[FDA Pilot Targets Faster Early-Stage Drug Trial Starts]]>

HHS’s Operation TrialBlazer

On Monday, June 22, 2026, the U.S. Department of Health and Human Services (“HHS”) announced Operation TrialBlazer, a coordinated department-wide initiative aimed at promoting clin...

<![CDATA[The Difference Between Real-Time Clinical Data Review and Real-Time Clinical Trial Oversight]]>

<![CDATA[FDA’s New Pilot Program and Real-Time Review of Clinical Data]]>

<![CDATA[Right–to-Try Does Not Undermine Clinical Trials]]>

Federal health agencies unveil plan to speed up phase 1 clinical trials by 6 to 12 months

As the biotech world flocks to San Diego today for the BIO International Convention, the Department of Health and Human Services has provided plenty of conversation fodder with the...

<![CDATA[Does FDA's Shift From Two Pivotal Trials to One Represent a Genuine Evolution?]]>

China’s National Medical Products Administration Releases Implementation Measures for Drug Trial Data Protection – May 3...

On May 15, 2026, China’s National Medical Products Administration (NMPA) released the Implementation Measures for Drug Trial Data Protection (药品试验数据保护实施办法), effective M...

HHS plan to speed drug research won’t remove ‘self-inflicted’ delays

U.S. clinical trials continue to lose ground to China, but is Operation Trialblazer enough to help America catch up?

Clinical Trials Updates

The registration of clinical trials prior to the start of a clinical trial is now extremely important part of the protocol. Here is a statement from International Committee of Medi...

Two Roads to Fast Clinical Trials, and the US Takes Neither

The HHS (FDA, NIH, ARPA-H and related agencies) is moving to speed clinical trials in what they are calling Operation TrialBlazer (kudos on the pun). The motivator, of course, is C...

<![CDATA[How Basket-Trials are Reshaping Drug Development Timelines]]>

<![CDATA[Pharmaceutical Executive Daily: FDA Pilot Targets Faster Early-Stage Drug Trial Starts]]>

<![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]>

The FDA’s Bayesian Guidance Could Quietly Reshape Clinical Trial Design

New FDA guidance on the use of Bayesian statistics signals a broader shift in accommodating more flexible clinical trial designs and the complexities of diseases such as certain ca...

FDA clears CTA313 trial for progressive MS, autoimmune diseases

Imviva Biotech is cleared to launch a basket Phase 1b trial testing its investigational off-the-shelf CAR T-cell therapy CTA313 in progressive multiple sclerosis (MS) and other B-c...

CMS Announces RAPID Coverage Pathway to Speed Medicare Coverage of New Medical Devices

The Gap Between FDA Authorization and Medicare Coverage In April 2026, the Centers for Medicare & Medicaid Services (“CMS”) and the U.S. Food and Drug Administration (“FDA”) an...

FDA Breakthrough Therapy and RMAT: Strategic Decisions That Can Accelerate Oncology Development

Explore how FDA Breakthrough Therapy and RMAT designations can create opportunities for oncology programs when backed by the right development strategy.

China’s National Medical Products Administration Releases Interpretation of the “Implementation Measures for the Measure...

In follow up to the May 15, 2026 release of the Implementation Measures for the Measures for Drug Trial Data Protection (药品试验数据保护实施办法), China’s National Medical Product...

Why City of Hope Built a National Clinical Trials Platform Designed to Scale With Oncology Innovation

City of Hope built a national trials engine to move oncology innovation faster, wider and with the scale sponsors need.