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The US Food and Drug Administration (FDA) received a broad range of comments concerning its draft guidance on selecting, developing, or modifying clinical outcome assessments (COA) in patient-focused drug development (PFDD), with most stakeholders wanting to know how new terminology introduced in the guidance would fit in with the agency’s overall PFDD program.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Congress has passed a stop gap funding bill that includes the reauthorization of the US Food and Drug Administration’s user fee programs. The reauthorization would avert layoffs at FDA and secures funding for numerous initiatives at the agency tha...
More than one-third of accelerated approval applications do not meet their original confirmatory trial dates, and four drug applications were more than 5 years past their confirmatory trial deadlines, according to a recent report released by the U...
The US Food and Drug Administration (FDA) announced this week it has elevated and reorganized its Office of Tissues and Advanced Therapies (OTAT) to a “Super Office” within the Center of Biologics Research and Evaluation (CBER) to meet its growing...
The FDA’s Quality Management System Regulation (QMSR) proposal, paired with the International Organization for Standardization’s ISO 13485:2016, is expected to deliver cost savings to medtech organizations that adhere to both requir...
The US Food and Drug Administration’s (FDA) final guidance on clinical decision support (CDS) software goes against the statutory language laid out in the 21 st Century Cures Act , according to a legal expert following the matter. While the guid...
National medicines regulators in six European countries are now actively prompting clinical trial sponsors to publish the results of their past studies. Advocacy group TranspariMED said their efforts have been “remarkably successful” but warned th...
A German manufacturer of OTC products and a Chinese supplier of active pharmaceutical ingredients (APIs) were told to adopt better equipment cleaning practices in recent warning letters from the US Food and Drug Administration (FDA). The letters, ...
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how...
The US Food and Drug Administration (FDA) has released updated guidance on COVID-19 diagnostic and serology testing, signaling its intention to review fewer emergency use authorizations (EUAs) for new tests moving forward.
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human subject protections and Institutional Review Boards (IRBs) with the revised Common Rule, whic...
Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License Applications (BLA) for Real-Time Oncology Review (RTOR) want more c...