Newsletter - June 22, 2023
FDA Lists the Most Common GMP Deficiencies Last Year
The annual report by the Office of Pharmaceutical Quality (OPQ) lists several updates regarding FDA’s CGMP inspection program along with several interesting factoids about the status of the drug supply chain in the US. The FDA has been developing a new inspection program for the last few years...Read More
Race-Based Disease Scores: Good for One, Not for The Other
About a year ago, the National Kidney Foundation updated the formula for calculating the estimated Glomerular Filtration Rate (eGFR) by eliminating the race-criteria because it was found that the race-based algorithm incorporating GFR is delaying diagnosis and treatment of worsening chronic kidney disease (CKD). Read More
FDA Lists the Most Common GMP Deficiencies Last Year
The annual report by the Office of Pharmaceutical Quality (OPQ) lists several updates regarding FDA’s CGMP inspection program along with several interesting factoids about the status of the drug supply chain in the US. The FDA has been developing a new inspection program for the last few years...Read More
Race-Based Disease Scores: Good for One, Not for The Other
About a year ago, the National Kidney Foundation updated the formula for calculating the estimated Glomerular Filtration Rate (eGFR) by eliminating the race-criteria because it was found that the race-based algorithm incorporating GFR is delaying diagnosis and treatment of worsening chronic kidney disease (CKD). Read More