SQA

JUNE 10, 2021

Due to the COVID-19 pandemic, there was an increase of 39.2% Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). on regulations published by ANVISA. The deadline for comments is 30 June 2021.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

SQA

DECEMBER 16, 2022

19 Medical Rehabilitation Equipment. 26 of 2014. Medicine shortages and reduced availability of medicine represent an increasing issue across the European Union (EU) and the globe, which has been amplified by the COVID-19 pandemic. United States Food and Drug Administration (FDA) – Regulations and guidance.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

SEPTEMBER 2, 2022

ANVISA published the RDC 702/2022, which repeals some requirements that were instituted to speed market approval of devices needed to treat patients during the height of the COVID-19 pandemic. The Agency recently published the first list of critical medicines for the management of the COVID-19 pandemic.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

FEBRUARY 26, 2024

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

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

FEBRUARY 29, 2024

Not to mention, it is a powerful defense for our clients in product liability matters because it can foreclose liability and plaintiffs’ use of tort lawsuits (invariably creatures of state law origin) to impose requirements on medical devices or pharmaceuticals that the federal FDA did not. What could be better than preemption? See 42 U.S.C.

COVID-19 59

COVID-19 Informed Consent FDA Governance 59