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As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
The FDA has called out three drugmakers for lack of compliance with current good manufacturing practices (cGMP) and marketing unapproved products, among other lapses. Read More
AdvaMed commended CMS for its July 10 proposed rule that includes separate payments for diagnostic radiopharmaceuticals are used to diagnose and treat diseases such as Alzheimer’s and cancer. Read More
A Texas pharmaceutical marketer was sentenced to two years and five months in federal prison and ordered to pay over $59 million in restitution for conspiring to defraud the US, receiving illegal kickbacks in exchange for compounded medications prescription referrals, and money laundering. Read More
This week, the FDA published a final guidance on clinical considerations for studies of opioid use devices. Draft guidances were issued for misinformation about drugs and devices, use-related risk analyses and 510(k) submissions for dental composite resins and dental curing lights. Read More
Hamilton Medical has issued a recall for correction of the software in one of its ventilators, an issue that could cause the device to fail during procedures, a recall which the FDA has deemed Class I, the most serious type as use may cause serious injury or death. Read More
The FDA offers new recommendations for testing and information to include in 510(k) submissions for dental resin devices and the ultraviolet curing lights used to set the resins, in two new draft guidances released Friday. Read More
The FDA issued a complete response letter (CRL) to Novo Nordisk for insulin icodec — a once-weekly long-acting human insulin analogue — raising questions about the manufacturing process and the type 1 diabetes indication. Read More
The FDA has finalized its guidance on crafting phase 3 clinical trials for devices designed to treat opioid use disorder (OUD), providing sponsors with direction on defining patient populations, recording medication use, monitoring drug use and other elements. Read More
Health care providers and facilities are being warned by the FDA to stop using Medtronic NIM (neural integrity monitor) Contact EMG (electromyogram) reinforced endotracheal tubes and NIM Standard EMG reinforced endotracheal tubes. Read More
Lost in the politics-oriented follow up to the presidential debate between Joe Biden and Donald Trump was the substance of what they both said during the debate about the actual issues — and a number of these issues potentially involve the FDA. Read More
The FTC submitted a comment supporting a proposed US Patent and Trademark Office (USPTO) rule to address patent system abuse such as the creation of overlapping patent rights known as patent thickets, which can block or delay competition, a problem especially apparent in bringing generics and biosimilar drugs to market. Read More