ePT--the Electronic Newsletter of Pharmaceutical Technology
Kevin Sharer has become chairman of the board of the Pharmaceutical Research and Manufacturers of America upon the resignation of Peter R. Dolan.
Washington, DC (Sept. 15)-Kevin Sharer has become chairman of the board of the Pharmaceutical Research and Manufacturers of America (PhRMA, www.phrma.org) upon the resignation of Peter R. Dolan. Sharer is currently president, CEO, and chairman of Amgen.
Sharer emphasized PhRMA's commitment to “drive American innovation, confront the toughest healthcare problems, deliver great value to patients, and make medicines available to patients who need them.” He added that PhRMA will “continue partnering with patients, physicians, and other healthcare stakeholders to achieve these goals.”
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.