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

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? So I picked the Ed Sheeran song, The A Team, because it reminds me of our ACE team that goes around the hospital and cares for our older patients. And a light bulb just went off in my head, like, yes, this makes sense as a model for how we should care for more complex older patients.

Hospital 101

Hospital Patient-Centered IT Nurse Practitioner 101

FDA Law Blog

JANUARY 4, 2023

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). By Holly N.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

GeriPal

DECEMBER 2, 2022

He wrote a book titled “ Psychiatric consultation in long term care ” that has a strengths based approach to staging dementia (how cool is that). She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. And the person with dementia, the patient, said yes.

Community 102

Community IT Individual Patient-Centered 102

GeriPal

OCTOBER 12, 2023

Summary Transcript Summary For surgeons and patients, deciding if and when to operate can be challenging. Often, the way surgeons communicate about these decisions doesn’t make things any easier for themselves or their patients. We hope you enjoy this episode. And that’s how we connected.

IT 129

IT Families Family Patient-Centered 129

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. Jennifer 04:25 I can take that on. Eric 05:32 Yeah.

Patient-Centered 120

Patient-Centered IT Patients Hospital 120

GeriPal

NOVEMBER 3, 2022

You’d imagine though that our professional expertise and experiences in helping patients and families cope with loss and grief would be helpful in managing our own personal losses. Eric: We’re going to be talking about loss and grief and the role of debriefing for healthcare providers. Turns out, it’s maybe not. She was homeless.

Healthcare Professional 103

Healthcare Professional Healthcare IT Relationship 103