ANDA Sponsors Given More Paperwork, But New Cover Letter Could Actually Be A Time-Saver
Optional checklists will help ensure submissions have all the required information.
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Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.
Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.
Increasing number of product development meetings suggests that many complex generics remain in the development stages.