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The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical Device User Fee Amendments (MDUFA VI) program for the next five fiscal years.

The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions about the necessity of inspections and clarifies the agency’s use of alternative methods instead of relying solely on onsite inspections.

Industry groups are asking the US Food and Drug Administration (FDA) for greater transparency into its Commissioner's National Priority Voucher (CNPV) pilot, including how the agency intends to transition the pilot into a full-fledged program.

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

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.