FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. Finally, mark your calendars for the upcoming March 22, 2022 FDA webinar about this Guidance. The FDA webinar information can be found here.

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., How can the FDA facilitate individuals accessing medical technologies in remote locations when they are unable or unwilling to access care in clinical settings?

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

SEPTEMBER 20, 2021

First, CDER will publish a new MAPP (the Manual for Policies and Procedures, meant to guide CDER staff in their review activities and interactions with sponsors) describing: (1) early engagement with sponsors and (2) “science- and risk-based approaches” for CMC development that “may be warranted and utilized.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. webinar":{"type":"Static","pageId":"dxdvv"},"./in-the-know":{"type":"Static","pageId":"rp7qt"},"./direct-primary-care":{"type":"Static","pageId":"b42ky"},"./zo-3-step-peel":{"type":"Static","pageId":"xj7v1"},". schedule":{"type":"Static","pageId":"tg6i2"},"./medspa":{"type":"Static","pageId":"hr7g7"},"./meet-the-team":{"type":"Static","pageId":"w0jmf"},"./webinar":{"type":"Static","pageId":"dxdvv"},"./in-the-

Referral 40

Referral DO Family Medicine Primary Care 40