FDA Law Blog

JULY 17, 2024

Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Patients 59

Patients Patient-Centered Clinic Medical 59

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

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT 121

IT Patient-Centered Patients Clinic 121

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Dave noted the Diplomate Professional Profile’s potential outside of Specialty Board discussions with data that could be valuable to patients with specific needs and conditions.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? So I picked the Ed Sheeran song, The A Team, because it reminds me of our ACE team that goes around the hospital and cares for our older patients. And a light bulb just went off in my head, like, yes, this makes sense as a model for how we should care for more complex older patients.

Hospital 101

Hospital Patient-Centered IT Nurse Practitioner 101