FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

JULY 5, 2023

Outsourcing facilities are not exempt from FDA’s cGMP for drug manufacturers (as lightly tweaked via cGMP Guidance for outsourcing facilities ) or adverse event reporting requirements , and are subject to regular inspection by FDA. Section II at 2. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

IT 102

IT Screening Hospital Clinic 102

FDA Law

JUNE 4, 2025

Indications for chronic diseases do not generally reflect the length of the clinical trial; FDA determines that clinical trials supporting such approvals are of sufficient duration and makes an approval determination.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast.

Healthcare 128

Healthcare IT Education Community 128

FDA Law

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). If you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. Dr. Maisel also discussed disposition of already distributed devices.

Manufacturing 59

Manufacturing Medical Patient-Centered Provider 59