June 16, 2020 · FLEMING | NOLEN | JEZ, L.L.P.
The FDA must approve a prescription drug before the manufacturer can sell it in the United States. Ordinarily, the approval process requires that the manufacturer first present clinical trial data as evidence for the effectiveness and safety of the drug. If a drug is too dangerous, or if the drug is not effective in treating the condition for which it…
November 8, 2017 · FLEMING | NOLEN | JEZ, L.L.P.
Three members of Congress recently sent a letter (PDF) to Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb, M.D. expressing deep concerns over the FDA’s inaction on Essure. The FDA allowed this dangerous product to remain on the market on the condition that its manufacturer, Bayer, conduct a post-market safety study a year and a half ago. However, it…