The General Accountability Office (GAO) should press the FDA to stop being passive in its oversight of device safety and instead take a more bold and active role, according to…

Enhanced access to real world data (RWD) sources critical to regulators, pharma companies and researchers is the objective for the two electronic catalogues launched last week by the European Medicines…

This edition of Quick Notes looks at consequential new drug approvals, including a first drug for frostbite, a first of its kind gene therapy authorization for sickle cell disease and…

Judges from the U.S. District Court of Massachusetts have revived a nearly 12-year-old lawsuit that charged Sanofi with damaging the health of patients with a rare liver disease by selling…

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. Source:…

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…

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…

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 Draft guidance was issued…

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…

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…