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

The Indian government has strengthened oversight of cell and gene therapies by bringing the novel modalities into the Centrally License Approving Authority (CLAA) framework.

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, FDA named the seven companies that will participate in its PreCheck Pilot Program and opened its total product life cycle advisory program (TAP) pilot to products overseen by all of its Offices of Health Technologies (OHT).

Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance of medical devices.

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

The US Food and Drug Administration (FDA) recently warned a distributor and medical device maker for marketing continuous positive airway pressure (CPAP) machines and related software for treating sleep apnea without securing proper marketing authorization and for inadequate complaint handling. The agency also warned a device maker for misclassifying its products as premarket notification exempt pharmacy compounding kits.

Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) technologies can help improve early-phase clinical trials. They also said the agency should develop a governance structure with specific metrics and goals and consider aligning its thinking with other regulators.