FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

MAY 5, 2022

But when you talk to people about relationships, the fact that they’re trying to communicate at church or any kind of house of worship, or go out to meetings, the fact that people stop going out to events, that they restrict what they’re doing. But on the personal level, it’s an engagement issue as well. It’s amazing.

IT 102

IT Screening Hospital Clinic 102

The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. Natal alienation is, in part, the under-structure of the wider Medical-Industrial Complex and the gratuitous violence that fat, Black, trans folks experience. is rooted in anti-Blackness.

Community 52

Community Manufacturing Patients Medical 52

FDA Law Blog

JANUARY 8, 2023

The enactment of the Medical Marijuana and Cannabidiol Research Expansion Act (“the Act”) into law (Public Law 117-215) last month is a step in that direction. To date 39 states and the District of Columbia have legalized cannabis for medical use (and 21 for adult recreational use), mainly through ballot initiatives. 21 U.S.C. §

Medical 64

Medical Manufacturing Electronics Provider 64

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Then fast forward a year.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

DECEMBER 7, 2023

And it is going to affect, if it hasn’t already, our food quality, the food that’s available, our medications. There’s an issue with an extreme heat, the medications may lose its efficacy, and there’s certain medications that make someone more vulnerable to heat emissions- Eric: And the power outages that we see.

Healthcare 129

Healthcare IT Education Community 129

FDA Law Blog

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

Medical 59

Medical Manufacturing Patient-Centered Provider 59