Palvella Therapeutics Submits First Module of Rolling New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
The FDA has implemented a rolling review process to expedite evaluations of New Drug Applications (NDAs). This allows the FDA to review completed modules of the NDA before the entire application is submitted. The aim is to streamline the review process and accelerate the approval timeline, benefitting both the FDA and the applicants. This process is particularly beneficial in cases where time is crucial, allowing for earlier feedback and potentially speeding up the overall approval process.