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…the FTC Staff’s cross appeal. As a result, the final order is broader than the order issued by the ALJ in 2012. Specifically, the Commission concluded that: 36 (compared to…
On April 3, 2018, FDA announced that it had issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC…
…submitted to FDA and Health Canada within 6 months of acceptance of the pilot program: For FDA, specify if it is a 510(k), De Novo, or pre-market approval (PMA) original,…
…on behalf of the various state programs. In accordance with federal law, the Florida program will not import controlled substances, biological products, infused and parenteral drugs, intravenously injected drugs, or…
Last week, the U.S. House of Representatives passed H.R. 3161, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2008. The bill, which,…
…has been available by prescription since 1999. On August 24, 2006, FDA approved non-prescription use of Plan B for women 18 years and older. Women 17 years and younger, however,…
…manufacturers, wholesalers, repackagers, 3PLs, and dispensers (e.g., pharmacies). Beginning on January 1, 2015, manufacturers would be required to pass the transaction history (i.e., “pedigree”) with any prescription drug product they…
…more than half of all states mandate electronic prescription opioids, all controls, or all prescriptions) requires DEA to rethink its position on initial prescription transfers. This is especially important given…
…health system to hospitals, clinics, infusion pharmacies, long term care facilities. Sometimes, hospitals compound after receipt of a prescription, but they also compound before receipt of a prescription, and hold…
…on for approval, but rather a different drug: COLBENEMID, a fixed-dose combination drug product containing probenecid (500 mg) and colchicine (0.5 mg) FDA approved under NDA 012383 on July 27,…
…drug suppliers regulated under the laws of Canada or of one or more Canadian provinces, or both; ensure that only prescription drugs meeting the FDA’s safety, effectiveness, and other standards…
Colorado and Florida have joined Vermont in the list of states seeking to combat high prescription drug prices by establishing programs to import drugs from Canada. On April 29, 2019,…
…only by prescription. When the petitioners sought judicial review of FDA’s decision in 2006, Judge Korman, in 2009, vacated FDA’s Citizen Petition denial because of the “political considerations, delays, and [FDA’s]…
…however, he reneged on the promise and, instead, delayed action another eleven months to pursue, and then abandon, a rulemaking with respect to Plan B. There is also evidence that…
On March 29, 2017, Senator Al Franken (D-MN) and several other Senate Democrats introduced S. 771, the “Improving Access to Affordable Prescription Drugs Act.” A companion bill, H.R. 1776, was…