Between 1995 and 1999, Genentech focused on getting products to market and spent heavily on clinical development. That investment helped produce an impressive product pipeline that is the envy of the industry. But now it faces some major challenges as it attempts to increase its stature as a global player and prepares to sell its first mass market product.To help it achieve its ambitious goals, Genentech brought in Myrtle Potter, who has held senior management positions at Merck and Bristol-Myers Squibb, as COO and EVP, Commercial Operations.In this interview, Potter argues that Genentech's success in integrating the commercial and scientific ends of the business will serve the company well as it ramps up its commercial capabilities. She also says that because Genentech is facing head-to-head competition for the first time, it will require dramatically new commercialization strategies.

Agency officials can now discuss the ideas that have been accepted, though not in great detail.

FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.