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Sponsors who want to use digitally derived endpoints from digital health technologies (DHT) should validate those endpoints for the intended patient population, pre-specify their missing-data strategy at every level of their clinical trial, and avoid conflating device clearance with endpoint validation, according to US Food and Drug Administration (FDA) officials who spoke at a recent public meeting.

The US Food and Drug Administration (FDA) has published a draft guidance on how to design trials and analyze data from studies examining the pharmacokinetics (PK) and pharmacodynamics (PD) of drugs in patients with hepatic impairment (HI). The agency noted that impaired liver function can have a significant impact on how drugs are absorbed and filtered, requiring a better understanding of their effects.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The US Food and Drug Administration (FDA) could take additional steps to more successfully implement disclosures of complete response letters (CRLs) to the public, experts argued in a recent paper published in the Journal of Law and the Biosciences.

Industry and patient groups have asked the US Food and Drug Administration (FDA) to make several changes to its revised draft guidance on master protocols for drugs and biological products. Additionally, two industry groups pushed for greater harmonization with global regulators, while a group representing clinical trial sites questioned the practicality of the guidance when it comes to site-level operations.

The Indian government has simplified the regulatory framework for outsourced sterilization of medical devices as part of a push to support businesses.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

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. According to news reports, the Trump administration may create two more FDA executive positions in a possible bid to exert more control over the agency; FDA approved several first-of-its-kind treatments, including a drug that was approved well ahead of its decision date and a wearable device that tracks ketones and glucose levels.

The US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Alar Pharmaceuticals, accusing the company of making misleading claims regarding the safety and effectiveness of ALA-3000 (ketamine pamoate), its investigational new drug for treatment-resistant depression (TRD).

Drug manufacturing process models represent a "growing area" of scientific development and are increasingly being utilized in new drug applications (NDAs), biologics license applications (BLAs), and supplements to these applications, according to a recent review by US Food and Drug Administration (FDA) officials.