Frequently Asked Questions (FAQs) What is the right time for a drug developer/sponsor to apply for MIDD? MIDD approaches can add value throughout drug development; therefore, […]

Exceptions or additions to the recognized standards S = Susceptible; I = Intermediate; R = Resistant   Minimum Inhibitory Concentrations (mcg/mL)  Disk Diffusion (zone diameters in […]

[embedded content]   Espanol First comes the itching, then a red rash, and then blisters. These symptoms of poison ivy, poison oak, and poison sumac can emerge […]

Docket Number: FDA-2011-D-0720 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Implementation of ICH E2B(R3) The E2B(R3) document package comprises four materials. The […]

On January 21, 2025, the Food and Drug Administration approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic […]

On January 27, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ […]

What are “Novel” Drugs? “Novel” drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved […]

On This Page Date: October 11, 2023 Time: 8:50 a.m. – 2:50 p.m. ET Topics & Presentations Speakers 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials – […]

Image Español “FDA approved!” Maybe you saw those words on a company’s website or in a commercial promoting a product or treatment. Some marketers may say […]