No More 'Hidden' Facilities, US FDA Tells Generic Sponsors
Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.
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As the generic industry trade group warns shortages could emerge as number of manufacturers contracts, US FDA says many new firms gaining approvals and identifying facilities.
GDUFA II gives certain generics the possibility of an even faster review clock, which burnishes FDA's credentials in the drug pricing debate, but in order to take advantage, applications will need to be of high quality in addition to addressing a public health priority.
CDER Director Woodcock says it may not be necessary for the ANDA first-cycle approval rate to approach that for NDAs, but lowering the number of cycles to two would be desirable.