US FDA tells generic drug makers how to use 'controlled correspondence'
This article was originally published in SRA
The US Food and Drug Administration has for the first time attempted to formally define its so-called "controlled correspondence" process which generic drug companies have used for a number of years now to submit questions to the agency on specific elements of drug development1-3.
You may also be interested in...
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.