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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.

Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.

The US Food and Drug Administration (FDA) finalized two guidances on studies on 28 May to assist sponsors in establishing bioequivalence (BE) for new and generic drugs. One focuses on BE studies with pharmacokinetic (PK) endpoints, and the other on statistical methods for analyzing these studies.

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Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence.

The top generic drug regulator at the US Food and Drug Administration (FDA) on Wednesday touted the drop in refuse-to-receive (RTR) decisions his office issued for abbreviated new drug applications (ANDAs) in FY 2025 as a significant achievement for the agency.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This Week, FDA issued new guidance on organic impurities in antibiotics and sent a letter to combination product makers alerting them to potential nitrosamine impurities in products with a drug constituent.

The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA IV) program, while other topics, such as drug master files (DMFs) and forfeiture determinations are still being discussed.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, biostatistics experts took to JAMA to discuss the benefits and potential pitfalls of FDA’s recent draft guidance on Bayesian methods, FDA published a report on its GDUFA science program, and the agency released its OMUFA facility fee rates for FY 2026.

Officials from the US Food and Drug Administration (FDA) and representatives from the generic drug industry met on 19 February as part of the negotiations for the fourth iteration of the Generic Drug User Fee Amendments (GDUFA) program. The topics addressed during the meeting included drug master files (DMFs), internal consultations, and imminent actions.