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The historic 2023 approval of OTC naloxone was a highlight of the FDA’s efforts to combat the opioid overdose crisis, according to CDER’s year-end report on drug safety actions. Read More
Despite its denial of any wrongdoing, Pfizer has agreed to a settlement payment of $93 million to finally erase 12 years of antitrust litigation with drug distributors involving Lipitor, the pharma giant’s cholesterol drug. Read More
Senate Majority Whip Dick Durbin (D-Ill.) and Senator Mike Braun (R-Ind.) have urged the FDA to take “swift” action to update its enforcement tools to address the alarming proliferation of dangerous and misleading social media content promoting prescription drugs. Read More
The Dayton Chamber of Commerce doesn’t represent any of the pharmaceutical giants affected by the drug negotiation provision of the Inflation Reduction Act (IRA), HHS says in its motion to dismiss the complaint, nor does the Chamber’s geographically limited purpose connect it to the issue. Read More
The FDA has issued final guidance on charging for investigational new drugs in clinical trials, offering a minor update to its recommendations. In addition, the agency has published new draft and revised product-specific guidances and extended the comment period for its guidance on trial master protocols. Read More
The presentation and accuracy of medical information through traditional and social media — and even the headlines that accompany it — directly impact the nation’s health, FDA Commissioner Robert Califf told a gathering of reporters Wednesday in Washington, D.C. Read More
With the composition, practice and utilization of data monitoring committees (DMC) changing considerably over the years, the FDA has published a new draft guidance on their use in clinical trials that will modernize its advice on the subject. Read More
FTC and HHS are jointly seeking more intel on how the practices of two types of pharmaceutical drug middlemen — group purchasing organizations (GPOs) and drug wholesalers — may be contributing to generic drug shortages. Read More
Two online marketers of semaglutide (Wegovy/Ozempic) and tirzepatide (Mounjaro) received FDA warning letters for selling the unapproved, untested drugs to consumers through their websites. Read More