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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
It requires the FDA to submit an annual report to congressional committees that includes: (1) the number of devices approved in the preceding year for which there is a pediatric subpopulation that suffers from the disease; (2) the number of approved devices labeled for use in pediatric patients; (3) the number of fee-exempt devices approved ...
The statute authorizes the FDA to award a priority review voucher to the sponsor (manufacturer) of a newly approved drug or biologic that targets a neglected tropical disease or a rare pediatric disease. The provision applies to New Drug Applications (NDAs), Biological License Applications (BLAs) and 505(b)(2) applications. The voucher, which ...
Beyfortus, which will be marketed in the U.S. by Sanofi, is already approved in Canada, Europe and the U.K. Sanofi did The post New drug to protect babies, toddlers from RSV gets FDA approval ...
U.S. officials on Monday approved the first long-acting drug to protect babies and toddlers against a respiratory virus that sends tens of thousands of American children to the hospital each year.
The FDA granted 510(k) clearance to Medtronic plc's (NYSE: MDT) LINQ II Insertable Cardiac Monitor (ICM) system for use in pediatric patients over the age of 2 who have heart rhythm abnormalities ...
But for companies that approved between eight and 13 drugs over 10 years, the cost per drug went as high as $5.5 billion. [ 3 ] A new study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average cost was $1.3 billion, which was much lower compared to previous studies, which have placed the ...
WASHINGTON, Aug. 21, 2024 (GLOBE NEWSWIRE) -- The Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children’s National Hospital and funded by the Food and Drug Administration (FDA), announces today it is partnering with Additional Ventures, a nonprofit foundation focused on accelerating research progress and improving clinical care for individuals born with ...