2019 FDA Public Health World Health 
Exeed Regulatory Compliance
MARCH 5, 2020
A novel coronavirus, now called SARS-CoV-19, was first detected in the Hubei province of China in early December 2019. Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. There is now an FDA policy released on 29 Feb.
SQA
FEBRUARY 15, 2023
A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. China’s drug MAH system has been implemented nationwide since the revised Drug Administration Law came into force in 2019.
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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.
SQA
FEBRUARY 26, 2024
This guidance does not intend to elaborate on aspects related to the clinical evaluation or cybersecurity for these products, as those are described in other guidelines ( MDCG 2020-1 on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software; MDCG 2019-16 on Cybersecurity for medical devices).
Drug & Device Law
MAY 11, 2023
A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. The appellate brief from FDA bears that out well.
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