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.

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Manufacturing Provider Medical IT 98

GeriPal

JUNE 20, 2024

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Biological aging or physiological aging varies from individual to individual.

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IT Patient-Centered Patients Clinic 120

FDA Law Blog

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

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Clinic Manufacturing Patients IT 52

FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? In addition, the Checklist is not device-specific and may not reflect the data contained in the manufacturer’s premarket approval application (PMA). intrusion [into] the doctor-patient relationship.

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Manufacturing Provider Patients IT 52

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? 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. I’m guessing not. How to screen for hearing loss. Transcript.

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IT Screening Hospital Clinic 102

FDA Law Blog

SEPTEMBER 20, 2021

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. based upon the anticipated clinical benefit of earlier patient access to the product.”. Livornese and Josephine M.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JANUARY 8, 2023

Doctor-Patient Relationship. The Act mandates that DEA streamline and accelerate registration application procedures for cannabis researchers and manufacturers of cannabis for research. Cannabis Manufacturer Registration for Research. Cannabis Researcher Registrations. Application Process. 21 U.S.C. §

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Medical Manufacturing Electronics Provider 64