Remove 2001 Remove Consulting Remove Individual Remove Patient-Centered
article thumbnail

FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

FDA Law Blog

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

article thumbnail

A Podcast on Inhalant Misuse: From Glue to Galaxy Gas

PEMBlog

Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Inhalant misuse reported to Americas Poison Centers, 2001-2021. Patients that use these will repeatedly use it throughout the day. I would consult a toxicologist because I know that this is rare.

article thumbnail

Trump Whacks Agency That Makes the Nation’s Health Care Safer

Physicians News Digest

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.