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The US Food and Drug Administration (FDA) on Tuesday issued draft guidance on submitting investigational device exemption (IDE) applications electronically using the electronic Submission Template and Resource (eSTAR) template.

BOSTON – An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and reviewed some of the changes related to de novos being proposed under the Medical Device User Fee Amendments (MDUFA VI) program at The MedTech Conference last week.

The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to overseeing individualized gene editing (GE) products, including those that feature multiple product variants developed under a single investigational new drug application (IND).

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Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas touted the agency’s new rare disease framework as the best mechanism for modernizing rare disease development and incorporating the patient voice into scientific reviews for orphan therapies during a fireside chat at the NORD Breakthrough Summit on Monday.

Australia's Therapeutic Goods Administration (TGA) is holding a consultation into a planned temporary increase to medical device annual charges.

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

Regulatory and quality professionals work in an environment that requires constant learning and connection. To keep up with changes in healthcare and healthcare regulation, across medical devices, pharmaceuticals, and more, you need to stay up to date and meet people who can complement your knowledge and skills. 

BOSTON – There needs to be a cultural shift to foster trust between regulators and the medtech industry when developing real-world evidence (RWE) to support the marketing of medical devices, according to experts who spoke at The MedTech Conference on Monday. They also noted that developing standards is key to expanding the use of RWE.