We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Wayne Pines, Senior Director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, reviews the FDA’s recent actions related to marketing of drug products both to healthcare professionals and to consumers. Read More
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
Over the past week, the FDA issued a final rule on BLAs and master files. Final Guidance was issued on charging for investigational drugs under an IND. Draft guidance was issued on use of data monitoring committees. Product specific guidances were published. The agency also announced continuation of its site visit training program for its regulatory project managers, extended the comment period for the draft guidance on master protocols for drug and biological product development and amended a request for nominations for voting members for the Genetic Metabolic Diseases advisory committee. 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
This week, your watch can start alerting you to sleep apnea, a fingertip clip can monitor your daytime blood oxygen, and a robotic exoskeleton can help restore mobility to spinal cord injury patients. But in a refreshing win for actual humans, a large study finds that the surgeon’s hands are just as good as robotic techniques in arthroscopic knee repair. 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
The FDA has deemed Smiths Medical’s recall of its Medfusion model 4000 syringe pump as Class I for software issues that can make the pump fail and delay or interrupt therapy or fail to deliver therapy according to the programmed setting. 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