US FDA Preparing For Potential Bolus Of Complex Generic Applications
Increasing number of product development meetings suggests that many complex generics remain in the development stages.
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ANDA Sponsors Given More Paperwork
Optional checklists will help ensure submissions have all the required information.
Teva Identifies ‘Problem Pattern’ Of Complex CRLs Ahead Of GDUFA III
Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.
GDUFA III: Some Goals May Be Measured In Business Days Instead Of Calendar Days
ANDA user fee goals likely would have to be reconfigured to account for business days and still maintain the intended length of time.