For Immediate Release: February 14, 2024 The U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk […]
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 […]
The draft guidance for industry Drug Master Files describes how to prepare and submit DMFs. Here are some additional resources: Requesting a Pre-Assigned Application Number: To […]
Generic Drugs Patient Education Graphics; Health Care Professionals; Patients; Videos Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Public meeting: FDA Rare Disease Day 2024 […]
ACCRUFER ferric maltol July 25, 2019 Treatment of low iron stores Accrufer ADAKVEO crizanlizumab-tmca November 15, 2019 Treatment of vasooclusive crises in patients with sickle cell […]
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs […]
On This Page Date: January 18, 2024 Time: 1:00 PM – 3:00 PM ET Topics & Presentations Speakers A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry […]
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