by John A. Jenkins | Apr 9, 2026 | FDA, FOIA, Litigation, Medical Devices, Short-Selling, Stock Market
How FOIA Requests Signaled Problems With a “Bionic Pancreas” At a federal advisory panel meeting in 2018, a biomedical engineer named Ed Damiano stepped to the microphone – not just as a scientist. “I’m also a father,” he told regulators, describing his son’s...
by John A. Jenkins | Apr 1, 2026 | FDA, FOIA
FOIAengine: Advocates on Both Sides Push FDA for Data as a Senate Investigation Begins Even before Sen. Josh Hawley (R-Mo.) walked into a March 11 news conference to kick off an effort to ban the abortion drug mifepristone as unsafe – and days before he opened an...
by John A. Jenkins | Mar 26, 2026 | FDA, FOIA
FOIAengine: How FOIA Requests Pointed to Problems at Boston Scientific Months before Boston Scientific expanded its urgent warning this month about the risk of sudden death from its Accolade pacemakers, something quieter was happening inside the U.S. Food and Drug...
by John A. Jenkins | Feb 4, 2026 | FDA, FOIA, Litigation, Pharmaceuticals, Stock Market
FOIAengine: Media Requests Were Warnings, Months Before Bad News Hit In the early days of the Covid pandemic, there was big money on the line as pharmaceutical companies scrambled to produce vaccines. The world needed a miracle. The companies that could deliver it...
by Randy E. Miller | Jan 22, 2026 | FDA, FOIA, Law Firms
FOIAengine: A Tale of Two Law Firms When most people think about the Freedom of Information Act, they imagine journalists prying loose hidden facts or activists holding officials accountable. But FOIA is also a workhorse tool for lawyers. As two law firms’ 2025 FOIA...
by John A. Jenkins | Jan 14, 2026 | FDA, FOIA, News Media, Pharmaceuticals
FOIAengine: Warning Letters and Inspection Reports in the Spotlight Freedom of Information Act requests filed with the Food and Drug Administration by hedge funds last month revealed big financial players closely eyeing warning letters, enforcement documents, and...
