The Senate Committee on Appropriations has approved $2.6bn in funding to the US FDA for FY2016.
Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.
New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.
Hikma says its $2.65bn acquisition of Roxane Laboratories will make it the sixth largest firm in the US generics space.
Pharma firms may need to carry-out an analytical method comparability study as part of the life cycle management of a drug, according to final US FDA guidelines.
New faces in pharma in our weekly column.