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Over the last 15 years, there has been an uptick in the number of patents associated with small-molecule drugs approved by the US Food and Drug Administration (FDA), with a majority of the increase linked to the use of non-primary patents, according to the results of a recent special communication published in JAMA.

Michael Davis, the director of the FDA's Center for Drug Evaluation and Research (CDER), stated that increasing the availability of generic versions of glucagon-like peptide-1 (GLP-1) medications is a top priority for the agency to lower costs for Americans.

Consumer health groups urged the US Food and Drug Administration (FDA) to allocate more resources for testing generic drugs and to implement stricter metrics for postmarket safety reporting at a public meeting on Thursday discussing the reauthorization of the Generic Drug User Fee Amendments (GDUFA IV).

The US Food and Drug Administration (FDA) on Monday finalized guidance on its approach to making therapeutic equivalence (TE) evaluations and assigning therapeutic equivalence (TE) codes for abbreviated new drug applications (ANDAs). These codes are listed in the agency’s Orange Book and denote a drug’s bioequivalence to a reference-listed drug (RLD).

The US Food and Drug Administration (FDA) has updated its seven-year-old guidance to clarify the differences among abbreviated approval pathways and the data it will accept for these applications. These pathways include the traditional Abbreviated New Drug Application (ANDA) process under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the 505(b)(2) pathway.

Following months of negotiations with industry, the US Food and Drug Administration (FDA) has published its proposed commitment letter for the Generic Drug User Fee Amendments (GDUFA IV) program.

The US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. The rates are calculated by factoring in the agency’s resources against the number of applications it expects to receive over the next fiscal cycle based on historical trends.

The US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide products. These PSGs focus on peptide drugs used to treat conditions such as obesity, type 2 diabetes, osteoporosis, and macular degeneration.

Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any new framework for repurposing drugs does not disincentivize investment or competition and fits within agency’s existing statutory authority.

A recent report from the US Pharmacopeia (USP) reveals that drug shortages decreased by 23% in 2025; however, the duration of shortages is on the rise. Over 64% of the drugs that are currently in shortage have been unavailable for more than three years, and 39% have been in shortage for over five years.