article thumbnail

Welcome Dr. Ruffo

OCFM

Notice of Privacy Policy

article thumbnail

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

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).

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 Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2)

FDA Law Blog

For tissue-engineered medical products, examples may include biomechanical testing to assess the ability of a vascular graft to tolerate repeat access without leaking, permeability testing to assess the characteristics of a skin graft, or cellular distribution throughout a cell scaffold construct.

article thumbnail

New South Family Medicine and MedSpa Offers Next Level Care

New South Family Medicine and MedSpa

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.