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COLUMBUS, OH – The US Food and Drug Administration’s (FDA) top medical device official touted her center’s recent accomplishments and provided an update on several ongoing initiatives at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

WHITE OAK, MD – The US Food and Drug Administration (FDA) has announced plans for a future pilot program intended to facilitate the real-time review of clinical trials by regulators, as well as the launch of two proof-of-concept studies that will gather and report endpoints and other signals to regulators in real time.

COLUMBUS, OH – The US Food and Drug Administration (FDA) and representatives from industry have reached an agreement in principle on negotiations for reauthorization of the Medical Device User Fee Amendments (MDUFA VI) program, an FDA official told attendees at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

Fewer than half of the studies funded by the US National Institutes of Health (NIH) examined sex differences, despite a 2016 policy requiring grantees to report on them, according to a study published in Nature Communications Medicine.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing

Key changes with the QMSR include a greater focus on risk management, a culture of quality, and lifecycle integration. One of the biggest changes, officials said, is that risk is at the center of quality processes

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

Most drug and biological manufacturers met their postmarketing requirements (PMR) and postmarketing commitments (PMC) during fiscal year (FY) 2024, according to a report from the US Food and Drug Administration (FDA).

COLUMBUS, OH – Changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are in the pipeline, but a speaker at a recent meeting told attendees not to change their priorities based on proposed legislation.

CDSCO proposed the system in January 2026 as part of an amendment to the New Drugs and Clinical Trial Rules, 2019. The system is designed to allow companies to start some bioavailability and bioequivalence (BA/BE) studies after notifying authorities of their plans, rather than applying and waiting for permission to initiate the assessments. CDSCO proposed implementing the system 90 days after publication; that date passed last week.

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. The US Food and Drug Administration (FDA) made several announcements related to its new drug voucher program, highlighted efforts to reduce animal testing, and more.