SQA

AUGUST 8, 2023

TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. Although this Toolkit provides PCPC’s current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. TR 43 applies solely to empty glass containers.

FDA 40

FDA Compliance COVID-19 World Health 40

HIT Consultant

MAY 31, 2023

Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. A study on hospital market concentration found between 2007 and 2017, one single hospital system was serving 19% of the market — 11.2

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals FDA Telemedicine 96

Med League

NOVEMBER 23, 2022

In 2007, the US Food and Drug Administration issued a post market Alert “Carbamazepine significantly increases the risk of dangerous or even fatal skin reactions [SJS and TEN] in certain patient populations…the allele is almost exclusively found in patients with ancestry across broad areas of Asia, including South Asian Indians.”

Nurses 52

Nurses FDA COVID-19 52

Med League

NOVEMBER 23, 2022

In 2007, the US Food and Drug Administration issued a post market Alert “Carbamazepine significantly increases the risk of dangerous or even fatal skin reactions [SJS and TEN] in certain patient populations…the allele is almost exclusively found in patients with ancestry across broad areas of Asia, including South Asian Indians.”.

Nurses 52

Nurses FDA COVID-19 52