FDA determines that Wyeth Pharmaceuticals Cordarone (amiodarone hydrochloride) tablets, 200 mg, were not withdrawn from sale for reasons of safety or ...
Federal Register notice: A 9/14 joint advisory committee plans to review a Purdue Pharma supplemental NDA new for Butrans (buprenorphine) transdermal ...
Researchers question the value of clinical trials and the data they produce as used by FDA to grant accelerated approval to drugs and to approve panel...
Parexel executives say new drug sponsors could benefit from using an advantages/disadvantages matrix to prepare for a presubmission meeting with FDA s...
Health Affairs bloggers say FDAs new digital health approach raises as many questions as it answers.
FDA clears a Stryker 510(k) for the Serrato Pedicle Screw, intended for use in the non-cervical spine as part of the companys Xia 3 Spinal System.
FDA accepts for priority review a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) for use in patients with cutaneous T-cell lymph...
PhRMA questions whether FDA is trying to carry out too much research into drug advertising and promotion without having a clear, overarching research ...