New Drug Application (NDA) | FDA
The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the...
Types of Applications | FDA - U.S. Food and Drug Administration
An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate...
New Drug Application - Wikipedia
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
21 CFR Part 314 -- Applications for FDA Approval to Market a New Drug
Application, new drug application, or NDA is the application described under § 314.50, including all amendments and supplements to the application. An NDA refers to “stand-alone” applications submitted under section 505(b)(1) of the Federal Food, Drug, and …
Novel Drug Approvals at FDA | FDA - U.S. Food and Drug Administration
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 drugs and biological products.
U.S. FDA Extends Review of Pfizer’s New Drug Application for …
NEW YORK, December 20, 2022 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).
Understanding the New Drug Application Process: A …
Nov 6, 2024 · The New Drug Application (NDA) process is a complex journey that every new pharmaceutical product must navigate before it reaches the market. This comprehensive guide will explore the various aspects of the NDA process, its significance in the pharmaceutical landscape, and how contract research organizations (CROs) play …
Fresh from the biotech pipeline: record-breaking FDA approvals
Feb 26, 2024 · Nature Biotechnology - New drug approvals reached an all-time high in 2023, with five gene therapies, the first CRISPR–Cas9-edited therapy and a disease-modifying Alzheimer’s drug.
FDA's 505(b)(2) Explained: A Guide to New Drug Applications
Jul 17, 2024 · The 505 (b) (2) New Drug Application (NDA) provides a streamlined route for drug approval, making it a popular choice among many clients seeking FDA approval. Established by the Hatch-Waxman Amendments of 1984, this pathway refers to a specific section of the Federal Food, Drug, and Cosmetic Act.
Sunvozertinib New Drug Application in EGFR-Mutant NSCLC …
5 days ago · The new drug application (NDA) of sunvozertinib in relapsed/refractory non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations has been submitted to the FDA. The application is supported by data from the phase 2 WU-KONG1 part B study (NCT03974022). Data from WU-KONG1 part B were presented at the 2024 American Society of ...