SQA

DECEMBER 16, 2022

ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. ANVISA published answers to questions received during an online seminar on clinical research of medicinal cannabis held in May 2022. 26 of 2014. Agência Nacional de Vigilância Sanitária (ANVISA). CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

MAY 24, 2023

European Medicines Agency (EMA) Final GCP Guideline on Computerized Systems and Data Integrity, 11 April 2023 Following the draft guideline published in June 2021 the final EMA Guideline on computerized systems and data integrity in clinical trials has now been published. In addition, a new expression is defined: ALCOA+. audit trail).

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. The purpose of the note is to clarify that products for invasive aesthetic treatments cannot be regularized in the category of cosmetics.

FDA 52

FDA Compliance COVID-19 Public Health 52