FDA Law Blog

NOVEMBER 14, 2022

The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. The facility fee applies to a single manufacturing facility. Size, revenue, and number of finished drug products manufactured at a facility do not affect the OMUFA facility fee.

Manufacturing 52

Manufacturing Individual Management Provider 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. Because we don’t.

Illness 107

Illness IT Patient-Centered Patients 107

Common Sense Family Doctor

FEBRUARY 15, 2025

Food and Drug Administration (FDA) rule went into effect requiring television and radio advertisements for drugs to communicate risk and contraindications in a “clear, conspicuous, and neutral manner.” The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns. But it is not free.

Family Physician 40

Family Physician Manufacturing Family Families 40

FDA Law Blog

OCTOBER 17, 2023

This 2022 draft guidance proposed that certain non-addictive medical products for pain or addiction treatment could be eligible for breakthrough designation, aligning with the Agency’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law Blog

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. 29, 2023) (“Basis”); NPRM at 44,603. In 2023, HHS conducted a different approach, a two-part test, to determine whether marijuana has a CAMU. 44,597 (May 21, 2024). Basis at 61; NPRM at 44,615. *

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

OCTOBER 31, 2024

And when you look at the numbers, actually last year in 2023, even though we’re in a recovery phase, there were more than 75,000 deaths. And because MRNA vaccine someone nimbly manufacture, they can say hey, let’s just make a vaccine based on what’s currently circulating. Do I really, really want it? Eric 38:41 Okay.

Vaccination 127

Vaccination IT Patient-Centered Patients 127