Patient input can help inform the therapeutic context for regulatory review. Patient input also can inform the selection of clinical outcomes, ensure the appropriateness of instruments […]

FDA develops resources – workshops, webinars, and seminars – to help generic drug manufacturers improve the quality of their abbreviated new drug application (ANDA) submissions and […]

Action The U.S. Food and Drug Administration has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. Fabhalta is […]

Delivery Method: UPS Product: Drugs Recipient: Recipient Name Mr. Il Chong Chung Seindni Co., Ltd. 610-304, 16, Gireum-roSeongbuk-guSeoul02725South Korea Issuing Office: Center for Drug Evaluation and […]

Image CaptionScientist processing Ebola virus disease samples at Donka Hospital in Conakry, Guinea as part of the EVIDENT project. (Credit: EVIDENT) This project has been completed, […]

Thank you for joining us for another episode of the Guidance Recap Podcast. The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the […]

What should stakeholders consider when deciding to pursue an externally-led PFDD meeting? Given the expanse of diseases affecting the U.S. patient population and the effort required […]

FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Kevin Schneider Recipient Title Owner Intrathecal Compounding Specialist, LLC 206A Jacob’s RunScott, LA 70583-8907United States Issuing […]