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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Conversations in Drug Development Trends

The FDA, for example, has supported internally and externally led meetings and regularly hosts and attends meetings that include rare patient organizations as key attendees and/or co-presenters. For example, Voice of the Patient and Patient-Focused Drug Development meetings are focused on one disease or a group of similar diseases.

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Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules

FDA Law Blog: Biosimilars

The purpose of the public hearing is to receive factual evidence and expert opinion testimony on whether marijuana should be rescheduled to schedule III. Judge Mulrooneys prehearing ruling establishes the schedule for the parties presentations and established hearing guidelines. Prehearing Ruling (Dec. 4, 2024), at 1.

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Improving Romanian teachers’ LGBT+ related attitudes through an online intervention – the LGBT inclusion project

On Medicine

The intervention was designed for online delivery and included a recorded presentation, animations, testimonials by LGBT+ individuals, and two interactive exercises. We made sure to share links to all resources during the presentation and also sent them in PDF format to all participants.

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SAVE THE DATE: Drug Channels Leadership Forum, March 16-18, 2026

Drug Channels

Jeanine Robertson, Director of Pharmacy Network Relations, Liviniti WHAT TO EXPECT Expect bold, candid discussionsnot just presentations. Jason Dombi, Senior Vice President of Strategic Solutions, Cencora WATCH HIGHLIGHTS FROM DCLF 2025 Relive the #DCLF2025 energy and hear testimonials directly from participants. Click here.

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FDA Returns Disappointing News for ALS Stem Cell Therapy

PLOS: DNA Science

The amazing testimonials we have seen online do not align with the data that BrainStorm has shared with us or has been published in peer-reviewed publications. We have an obligation to the community we serve to be vigilant and data-driven, and our approach has served the ALS community well in recent FDA reviews.

Therapies 105
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What To Do When You Receive a DEA Order to Show Cause

FDA Law Blog: Biosimilars

Both the government (represented by DEA counsel) and you will have an opportunity to present your case through witness testimony and record evidence. The hearing closely resembles a trial, but the ALJ (rather than a jury) is the trier of fact. Hearings can range from half a day to several weeks, depending on the complexity of the case.

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Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

Improvement Rectifier Designation is designed to accelerate the development and review of pharmaceuticals intended to treat serious or life- menacing conditions with prelusive testimonial that indicates they may demonstrate a substantial enhancement over available rectifiers that have entered full FDA imprimatur.

Disease 52