On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic andr
This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products.
This material is intended to be a helpful resource that consolidates information relevant for drug manufacturers making products for the U.S. market. It is not a comprehensive list of all applicable statutory and regulatory requirements.
This guidance provides recommendations for the design and conduct of studies to evaluate the in 17 vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery 18 system (collectively referred to as TDS2).
FDA today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.
Information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.
Today, the Food and Drug Administration published 17 revised draft product-specific guidances (PSGs) for peptide products, marking Today, the Food and Drug Administration published 17 revised draft product-specific guidances (PSGs) for peptide products.
Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL).
Patient-focused drug development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. The primary goal of patient-focused drug development is to better incorpora
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020 to aid response efforts and ease the economic impact of COVID-19.
On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).