article thumbnail

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.

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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
article thumbnail

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
article thumbnail

Analysis Chemical Thank You Freedhoff testifies in front of Senate EPW over TSCA implementation

Agency IQ

The agency utilizes this process to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment. SHELLEY MOORE CAPITO (R-WV) opened the testimony. In anticipation of the hearing, Freedhoff submitted testimony reviewing the past 18 months of EPA actions on chemical regulation.

article thumbnail

Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Agency IQ

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

FDA 40
article thumbnail

Code breaking and the Human Genome Project

The Open Targets Blog

My impression from their testimonies is that they must have felt a great sense of a common purpose and the importance of their work, despite the necessary secrecy and sometimes drudgery involved. A diverse group of people were recruited to Bletchley Park. ranging from university academics through engineers and clerical staff to the military.

DNA 52