Joanne S. Eglovitch

The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices from premarket notification requirements.

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent an untitled letter to QOL Medical to “false or misleading” claims made in promotional emails for its congenital sucrase-isomaltase deficiency (CSID) treatment Sucraid (sacrosidase) oral solution.

The International Council for Harmonisation (ICH) has announced the adoption of Annex 2 to the guideline on Good Clinical Practices (GCPs) E6(R3). This annex focuses on the collection of data from a wider range of sources for clinical trials, including decentralized trials and pragmatic clinical trials (PCTs).

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.

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.

PHILADELPHIA – The US Food and Drug Administration’s (FDA) publication of complete response letters (CRLs) for unapproved drugs violates the agency’s own regulations and the Administrative Procedure Act, asserted Eva Temkin, an attorney with Arnold & Porter who spoke at the DIA Global Annual Meeting on Monday.

Philadelphia – Officials from the US Food and Drug Administration (FDA) discussed strategies for integrating artificial intelligence (AI) with real-world evidence (RWE) to advance drug development during a panel discussion at the DIA Global Annual Meeting on Tuesday. The officials noted there have been an increasing number of submissions that utilize both AI and RWE.

Philadelphia – Peter Stein, the former head of the US Food and Drug Administration's Office of New Drugs (OND), criticized the agency's Commissioner's National Priority Voucher Program (CNPV) and its one- to two-month review timeline, saying it's almost “an insult to the FDA reviewers.”

PHILADELPHIA – Officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) said that increased international collaboration is influencing the development of policies about artificial intelligence during the Drug Information Association's (DIA) Global Annual Meeting last week.

The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will collaborate with sponsors to develop and review protocols for first-in-human (FIH) clinical trials intended for investigational new drug (IND) submissions to FDA.