Complex ANDAs: Early Meetings With FDA Can Generate Bonus Communication
Executive Summary
By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.
You may also be interested in...
What’s Next? Five Things To Look Out For In January
A third biosimilar to Genentech’s Rituxan is set to hit the US this month, as players begin to publish full-year financial results encompassing a remarkable year.
FDA's Off-Patent, Off-Exclusivity List Draws Few Takers Early On
US agency has received 'very few' inquiries about the drugs on the list since its release.
Gottlieb Places Drug Pricing Out Front In First Speech To US FDA Staff
New FDA Commissioner tells employees that 'too many consumers are priced out of medicines they need' and that FDA must take meaningful steps to get lower cost alternatives to market.