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In an analysis that seeks to help frame the discussion at the upcoming Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, the FDA says that a law enacted in 2017 has increased the number of planned studies to test drugs for pediatric cancers compared to earlier regulatory laws. Read More
Joining three other Eugia Pharma plants in India, the company’s facility in Bhiwadi, Rajasthan, was handed a Form 483 from the FDA, citing observations of operators not following procedures in place to prevent microbial contamination of drug products, among other lapses. 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
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
Citing company “greed,” Sen. Bernie Sanders (I-Vt.) has again blasted Danish pharma Novo Nordisk for the prices of Wegovy and Ozempic, releasing a Senate committee report claiming the popular weight loss and diabetes drugs could bankrupt the US healthcare system. Read More
The FDA has published 32 new and revised draft product-specific guidances (PSG) which provide recommendations for developing generic drugs and the design of bioequivalence studies to support ANDAs. Read More
Eli Lilly entered into a settlement agreement with Totality Medispa for monetary payment and to halt further sale of unapproved versions of the company’s monumental Type 2 diabetes and weight loss drugs, Mounjaro and Zepbound (tirzepatide). Read More
More than 1,400 patents and patent applications — most filed years after drug approval — protect the US’ 10 top-selling drugs, heading off competition from generics or biosimilars for decades, a new study has found. Read More