International – Generic industry group wants clarity on ICH bioequivalence guideline
The Association for Accessible Medicines (AAM) said the US Food and Drug Administration (FDA) should ensure alignment between the International Council on Harmonisation’s (ICH)...
International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup
The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported...
International – ICH adopts M7(R2) guideline on mutagenic impurities to limit carcinogenic risk
The International Council for Harmonisation (ICH) earlier this week announced the adoption of its M7(R2) guideline that aims to harmonize the framework for assessing...
