Bill of Health

JULY 14, 2023

Public Health Service’s (USPHS) Syphilis Study at Tuskegee , whose revelation to the public sparked today’s legal schema for regulating and protecting the research it funds (the “Common Rule”), as well as research done in anticipation of receiving FDA approval for marketing a new product. While the U.S.

Informed Consent 130

Informed Consent FDA Public Health World Health 130

Health Law Pulse

FEBRUARY 11, 2022

During a recent Q&A, a representative with the World Health Organization warned that the Omicron variant is not the last of its kind. Norton Rose Fulbright lawyers will continue to provide relevant updates for healthcare providers on the Health Law Pulse during the COVID-19 public health crisis.

COVID-19 52

COVID-19 COVID-19 Vaccine FDA Public Health 52

SQA

FEBRUARY 15, 2023

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. Efforts should be made to promote and guide the use of electronic certificates.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

SQA

DECEMBER 16, 2022

SQA Regulatory Surveillance Summary for September and October 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. 30 of 2022.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

AUGUST 8, 2023

In August 2022, ANVISA published Resolution RDC 741/2022 , which sets the framework to consider other medical device market regulators’ authorizations. mg Strengths) Due to Possible Device Failure, 05 May 2023 Bausch Health, Canada Inc. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

OCTOBER 18, 2023

In addition, it contains essential recommendations to avoid complications and protect public health. The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products.

FDA 40

FDA Compliance Licensing World Health 40

SQA

OCTOBER 18, 2022

SQA Regulatory Surveillance Summary for July and August 2022. Health Canada. Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022. Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. Taro Pharmaceuticals Inc.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40