FDA Law

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

MARCH 7, 2022

At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy. Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., Copies of the guidances can be found here and here.

Manufacturing 52

Manufacturing IT Relationship Medical 52

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. the wholesale distributor, repackager, relabeler). Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

GeriPal

MAY 5, 2022

Think about the last time you attended a talk on communication skills or goals of care discussions. Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? I’m guessing not. COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. Alex: (Singing).

IT 102

IT Screening Hospital Clinic 102

FDA Law

JUNE 4, 2025

However, as the Assessment notes, [t]here aremany possible adverse events for which there is inadequate evidence to accept or reject a causal relationship, which may otherwise lead manufacturers to opt not to include them in the labeling. complex public health issues within 100(!) The Assessment does not focus solely on safety.

Chronic Disease 59

Chronic Disease Government Chronic Condition Vaccination 59

GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

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. This includes EUAs and full marketing authorizations.

Manufacturing 59

Manufacturing Medical Patient-Centered Provider 59