FDA Law Blog

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 Draft Guidance III.B.2(d)

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

Physician's Practice

JUNE 9, 2025

Don't miss our previous episodes on immigration policy and the physician shortage , AI diagnostic tools , patient autonomy and malpractice law. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D.,

Management 52

Management Telemedicine Patients Insurance 52

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

MAY 5, 2022

But when you talk to people about relationships, the fact that they’re trying to communicate at church or any kind of house of worship, or go out to meetings, the fact that people stop going out to events, that they restrict what they’re doing. Hearing aids, you had six big manufacturers of hearing aids. It’s amazing.

IT 102

IT Screening Hospital Clinic 102

The Clinical Problem Solvers

NOVEMBER 6, 2023

Identify ways to navigate clinical interactions with patients while respecting them and affirming their experiences with food and fatness. All of this contributes to various mental health challenges that are consistent with surveillance in not only a wider police-state but also the patient-physician relationship.

Community 52

Community Manufacturing Patients Medical 52

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Then fast forward a year.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law Blog

JANUARY 8, 2023

Doctor-Patient Relationship. Also of great importance is the Act’s authorizing state-licensed physicians to advise patients or their legal guardians of the potential harms and benefits of cannabis derivatives as a medical treatment. Cannabis Manufacturer Registration for Research. 21 U.S.C. § Application Process.

Medical 64

Medical Manufacturing Electronics Provider 64

GeriPal

DECEMBER 7, 2023

And that’s a good thing to share with an older patient or client that making decisions about your activity. And so if we think of that relationship though, as these kinds of disasters increasing, so flooding, hurricanes, extreme heat and extreme cold, there are system level things to do. So you can just get it in there.

Healthcare 129

Healthcare IT Education Hospital 129

FDA Law Blog

NOVEMBER 8, 2022

If you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications.

Medical 59

Medical Manufacturing Patient-Centered Provider 59