US FDA Hoping To Spur More ANDA Pre-Submission Meetings During GDUFA III
The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval.
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With GDUFA III now almost at the five-month stage, the FDA has released draft guidance on product-specific guidance (PSG) meetings between FDA and a prospective applicant, as part of commitments set forth under the Generic Drug User Fee Act.
Teva CEO Kåre Schultz has weighed in on Novartis’ plans to conduct a strategic review for its Sandoz unit, while also airing frustrations over continued delays for complex products in the US.
A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.