Remove 2014 Remove FDA Remove World Health
article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

26 of 2014. The entry into force closes a long revision process, which has been driven jointly by PIC/S and the EMA GMP/GDP Inspectors Working Group (GMDP IWG) in close co-operation with the European Commission (EC) and the World Health Organization (WHO).

FDA 40
article thumbnail

SQA Regulatory Surveillance Summary for May and June 2024

SQA

Participants were from regulatory medicine agencies in low-, middle-, and high-income countries; experts on and developers of screening technologies and other key stakeholders, including the World Health Organization (WHO), Interpol, UNICEF, and the United States Pharmacopeia (USP).

FDA 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

The rules also cover other services that perform activities related to clinical analysis examinations, such as isolated (private) offices and pharmacies, which are considered health services since the publication of Law 13.021/2014. cosmetic regulatory framework. Consumer and product safety remains at the heart of our industry.

FDA 40
article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2022 – May

SQA

Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. 536/2014 on Clinical Trials, which will replace EU Annex 13. 536/2014 on Clinical Trials replacing EU Annex 13.

article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2024

SQA

The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides. PCPC provided feedback to the FDA on the development of an efficient electronic submission program (Cosmetics Direct) and recognizes that the FDA’s development of Cosmetics Direct is ongoing.

FDA 52
article thumbnail

Generic Causation Experts Excluded In Sweeping Ruling From The Acetaminophen MDL

Drug & Device Law

For another, the drug at issue has been used very widely for many decades and it is on the World Health Organization’s List of Essential Medicines. That FDA does not believe a true association requiring a warning exists is also obvious. The facts and posture are fairly simple.

FDA 52