Drug approvals, label changes, and FDA drug news.
The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmeti
Clinical Outcome Assessments (COA) Qualification Program Submissions
Resources and information for requestors interested in CDER’s Clinical Outcome Assessments (COA) Qualification Program. This update contains the Letter of Intent Template for the COA Qualification Program, as described under section 507 of the Federal Food, Drug, and Cosmetic Act.
FDA issues compounding risk alerts to communicate information to alert health care professionals to adverse events and outbreaks related to compounded drugs so that practitioners can more effectively protect patients from unsafe, ineffective, and poor quality compounded medicines.
PALSONIFY is a somatostatin receptor analog for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.
The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.
CDER Data Standards Program
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
YARTEMLEA is a prescription drug that is a MASP-2 inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).
The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an ANDA referencing that NDA drug product.
To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area.
On July 23-24, 2026, the Committee will discuss bulk drug substances being considered for inclusion on the 503A Bulks List.
Efficacy supplement (new or revised indication). cream, topical. Sponsor: Arcutis
The FDA dealt Lantheus’ bid to garner approval of its radiodiopharmaceutical diagnostic kit a setback due to manufacturing issues at a third-party facility.
Viridian Therapeutics’ Lumvoa is approved for treating both the chronic and active phases of thyroid eye disease. This drug will offer patients an alternative to Tepezza, an Amgen drug that had been the only approved therapy for this inflammatory eye disorder. The post FDA Approves Viridian’s Thyroid Eye Disease Drug, Competitor to a Blockbuster Amgen Med appeared first on MedCity News .
FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 150,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.
The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to efficiently identify illegal foreign tobacco products — including youth-appealing e-cigarettes — and con
This document outlines a working agreement between the Center for Drug Evaluation and Research (CDER) and the Office of the Chief Scientist.
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Abbvie Inc
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Deciphera Pharms
Original biologic license approval. injection. Sponsor: Viridian Therapeutics Inc
Prospective generic drug applicants and generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) establishment in their abbreviated new drug applications (ANDAs).