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.
You may also be interested in...
FDA Guides On Generic Product-Specific Meetings, Under GDUFA III Commitment
With GDUFA III now almost at the five-month stage, the FDA has released draft guidance on product-specific guidance (PSG) meetings between FDA and a prospective applicant, as part of commitments set forth under the Generic Drug User Fee Act.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 Comments On Sandoz Implications Amid Strategic Review
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.
Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes
A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.