FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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Manufacturing Provider Medical IT 98

FDA Law Blog

DECEMBER 12, 2022

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

Manufacturing 52

Manufacturing Provider Patients IT 52

FDA Law Blog

MAY 7, 2025

Regulatory Framework The AKS makes it a criminal felony to knowingly and willfully offer or pay any remuneration, directly or indirectly, to induce a person to order or refer patients for medical care that is reimbursable under a federal healthcare program (e.g., Medicare or Medicaid).

Referral 59

Referral Relationship Government Healthcare 59

GeriPal

JUNE 20, 2024

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. 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

For this last question, FDA explains that it anticipates the sponsor would charge the patient directly or would charge a payor if reimbursement were available, but clearly states that FDA has no authority in this arena. Authorization for Charging in the Clinical Trial Context.

Clinic 52

Clinic Manufacturing Patients IT 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

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.

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IT Screening Hospital Clinic 102