All articles tagged with #regulatory guidance
The FDA issued a draft guidance showing how sponsors can reuse existing public data—such as CMC, nonclinical and clinical results—to streamline regulatory submissions for somatic genome-editing therapies, with the goal of accelerating access for patients with rare or life-threatening diseases while maintaining safety and efficacy; sponsors are encouraged to engage early (e.g., INTERACT) and submit comments within 90 days.
The FDA issued a draft guidance outlining a Plausible Mechanism Framework to accelerate approvals of genome-editing and RNA-based, individualized therapies that target the root causes of ultra-rare diseases, allowing smaller, robust studies and the use of master protocols. Sponsors must demonstrate the therapy addresses the specific disease mechanism, rely on well-characterized natural history data, and show target engagement or editing; public comments are due within 60 days.
Binance, the world's largest cryptocurrency exchange, is withdrawing from the Canadian market due to regulatory guidance surrounding stablecoins and investor limits. The company expressed its willingness to collaborate and communicate with Canadian regulators and hopes that a thoughtful framework will be established in the future, potentially paving the way for Binance to resume its services for Canadians. Canadian users will receive an email containing crucial details about how their accounts will be affected in the future.
The US Securities and Exchange Commission (SEC) has been ordered by a US court to respond to Coinbase's complaint over how it applies securities laws to digital assets within 10 days. Coinbase argued that the SEC is providing insufficient regulatory guidance for US companies operating in the crypto sector. The crypto exchange referred back to a 2022 petition asking for formal rulemaking within the digital assets sector, to which the SEC is yet to respond. Coinbase has been attempting to launch a pre-emptive strike against the SEC, which said in March it expected to sue the exchange over allegations of offering unregistered securities products.