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The FDA continued its implementation of new authorities for certain over-the-counter (OTC) drugs on Friday when it posted a final administrative order for OTC sunscreens. Read More
Two foreign manufactures have been sent FDA warning letters, highlighting sloppy testing of over-the-counter (OTC) analgesics and inadmissible marketing. Read More
The Department of Defense (DoD) is over-reliant on foreign drug supply chains, a problem that could spell big trouble not only for the military, but the entire country, says a new report from the DOD’s Office of the Inspector General (OIG). Read More
A Centers for Disease Control and Prevention (CDC) expert panel yesterday voted 9 to 6 that people aged 18-49 with underlying health conditions should be eligible to receive a booster vaccine, but voted down, 6 to 9, recommending a booster shot for people in that age group at risk of contracting the coronavirus based on their workplace. Read More
A Delaware court ruled Wednesday that Takeda Pharmaceutical is liable for damages to AbbVie for failing to supply its hormone therapy Lupron Depot (leuprolide acetate for depot suspension) according to the contract. Read More
The Health Resources and Services Administration (HRSA) has sent letters to six pharmaceutical companies — AstraZeneca, Eli Lilly, Novartis, Novo Nordisk, Sanofi, and United Therapeutics — letting them know their failure to comply with the 340B drug discount program has been referred to the Office of Inspector General at HHS. And several of the companies are pushing back. Read More
A federal court has ruled that the FDA must do more work on its regulation of compounding pharmacies before it can enforce a final standard issued last year. Read More
The White House Office of Management and Budget (OMB) has instructed all federal agencies, including the FDA, to prepare contingency plans in case government funding expires on Sept. 30. Read More
One of the most important obligations for researchers seeking UK clinical trial approval is to determine from the start how they will disseminate their study results publicly. Read More