Having received marketing authorization from the US Food and Drug Administration, the First To Know Syphilis Test from Arkansas-based NOWDiagnostics becomes the first at-home test to detect the sexually transmitted disease without a prescription.
NOWDiagnostics Wins De Novo For First OTC Syphilis Test
The US FDA has granted marketing authorization to NOWDiagnostics for the first at-home over-the-counter test to detect syphilis, which the government says is on the rise.
More from Regulation
• By
The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.
• By
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
• By
A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.
• By
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
More from Policy & Regulation
• By
Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
• By
Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.
• By
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.