Regulatory Focus

The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to overseeing individualized gene editing (GE) products, including those that feature multiple product variants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

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

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.

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.

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. This week, a drug safety group filed a citizen petition with FDA opposing the marketing of unapproved compounded peptides, a bipartisan bill was introduced to reform clinical trial participation and review, and more.

The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter International and Olympus Medical Systems—for good manufacturing practice (GMP) and Quality System Regulation (QSR) violations.