FDA Law Blog

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 Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. After reviewing the information. What is going on here? Draft Guidance. Public Comments.

Manufacturing 52

Manufacturing Provider Patients Medical 52

FDA Law Blog

SEPTEMBER 6, 2022

Below we outline the Draft Guidance and highlight the new information in the 2022 Draft Guidance. Two of the new questions added in the Draft Guidance (Q22 and Q23) address the fact that monitoring and other administrative “startup” costs, and manufacturing costs are often higher in the first year compared to subsequent years.

Clinic 52

Clinic Manufacturing Patients IT 52

GeriPal

JUNE 20, 2024

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. I don’t see those perspectives as incompatible.

IT 120

IT Patient-Centered Patients Clinic 120

FDA Law Blog

MAY 7, 2025

Seventh Circuit ruling in Sorensen In Sorensen , the government alleged, and the District Court agreed, that Sorensen paid illegal kickbacks to marketing firms based on the number of leads generated and a DME manufacturer based on the percentage of funds collected from Medicare.

Referral 59

Referral Relationship Government Healthcare 59

FDA Law Blog

SEPTEMBER 20, 2021

requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. But individuals who have hearing loss, there’s several problems. How to screen for hearing loss.

IT 102

IT Screening Hospital Clinic 102