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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 that arose from months of negotiations with industry.
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 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...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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...
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the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how...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...
Lawmakers have struck an eleventh-hour deal to renew the US Food and Drug Administration’s (FDA) user fee programs. With just four days to go before the current programs expire, Democrats conceded to Republican demands for a “clean” reauthorizatio...
Australia is holding a consultation on whether to allow advertisers to make references to the Therapeutic Goods Administration (TGA) in their promotional materials. TGA is seeking feedback on a wide range of options, from maintaining the current p...