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One of the biggest mistakes companies make in their responses to the FDA’s inspection observations is to focus on the specific issues raised without looking at the bigger picture, according to one regulatory compliance expert. Read More
NIH is seeking comments on a new policy that would require partnering organizations who receive institute funding to submit a plan outlining steps they will take — through a patent licensing agreement — to promote patient access to any resulting drug, biologic, vaccine or device. Read More
Magellan Diagnostics has agreed to plead guilty and pay $42 million for concealing a device malfunction for years that produced inaccurately low lead test results for potentially tens of thousands of children and other patients, including pregnant women. Read More
Congress needs to put more pressure on agencies like the FDA and the US Patent and Trademark Office (USPTO) to collaborate on fighting patent thickets, the multiple patents pharmaceutical companies file after a drug is already on the market to extend the drug’s period of exclusivity and keep generic alternatives off the market. Read More
The FDA has a lot of work to do to regain trust among a wide swath of demographic groups — starting with women — according to a recent survey. Read More
Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the landscape for the “clear, conspicuous and neutral” manner now required for direct-to-consumer marketing of drugs and devices. Read More
Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the landscape for the “clear, conspicuous and neutral” manner now required for direct-to-consumer marketing of drugs and devices. Read More
The FDA has imposed import alerts on two additional Chinese manufacturers of plastic syringes, preventing these products from entering the US, and is warning healthcare practitioners as well as consumers to transition away from the devices. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
The company previously recalled the device because it could unexpectedly stop and start and because of the potential for extrinsic outflow graft obstruction. Read More