Joanne S. Eglovitch
Latest From Joanne S. Eglovitch
Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
Accelerated development of COVID-19 products prompts World Health Organization to revise a guideline on good manufacturing practices for investigational drugs and propose a new guideline applying GMP principles to R&D facilities.
More manufacturers are contributing their analytical data to an excipient database to pool knowledge on the risk posed by excipients that may cause drugs to exceed acceptable PDE levels under ICH Q3D.
The pharmaceutical industry is doing a better job of conducting the risk assessments called for in the ICH Q3D elemental impurity limits guideline, and regulators are not rejecting applications because of poor quality assessments, yet regulators say there is still room for improvement.
Inter-associations working group suggests changes to the EU GMP Annex I revision to make it easier to understand by health authorities worldwide; the groups point out that the annex will be used globally and not just in Europe.
Physicians who compound drugs in their offices for patients will not be inspected as FDA decides to exercise discretion, recent final guidance said.