18 June 2019 - Generic drug applicants will now have more information from the US FDA when deciding whether to file a generic drug application, which could potentially increase the odds of earlier approvals, the agency said on Tuesday.

Previously, FDA’s Paragraph IV Patent Certifications List included only the name of the drug (along with the dosage form and strength) and the date on which the first substantially complete generic drug application that contained a Paragraph IV certification was submitted to the agency. 

But potential generic applicants may not have been certain on whether an application previously submitted to FDA might be eligible for 180-day exclusivity.

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