The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to their abbreviated new drug applications (ANDAs). The agency also finalized another guidance explaining its responsibilities for maintaining and updating the Orange Book, which contains lists patent and exclusivity information for drugs with therapeutic equivalence evaluations.
On 22 July, FDA published two final guidances. The first titled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe lays out how much the agency is willing to work with sponsors who receive a CRL stating their application needs more information before the agency will consider approving it…
