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In the News

November 29, 2018
Executive Summary Industry faces an uphill fight in a last-ditch effort to reverse the Medicare “donut hole” changes enacted at the start of 2018. At the same time, a stand-off over OTC monograph... Read more
November 28, 2018
Executive Summary Agency has targeted 40 older generic chemotherapeutics for revised labeling; FDA will develop the new labeling, which will include currently accepted uses, but needs the cooperation... Read more
November 28, 2018
Executive Summary US FDA and CMS explore reimbursement ideas to strengthen business case for antimicrobial development; new approval pathway likely is only needed in special situations. Bundle of... Read more
November 27, 2018
Executive Summary When is a two-week review not a two-week review? When it is part of the US FDA’s Oncology Center of Excellence “real-time review” pilot program. The “left shifted” review pilot is... Read more
November 26, 2018
Executive Summary Pilot project allows FDA conclusions about a drug’s efficacy and safety to be integrated with, but distinguished from, a sponsor’s own analysis; though currently used for reviews of... Read more
November 26, 2018
Executive Summary US FDA's drug center has been hiring more employees than it has lost over the last few months and hopes the Office of New Drugs reorganization will help retention.   The US FDA's... Read more
November 26, 2018
Executive Summary Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular... Read more
November 25, 2018
Executive Summary Three center directors agree that Gottlieb’s facility for public communications is a boon for FDA – and that the commissioner is appropriately hands-off when it comes to day-to-day... Read more
November 21, 2018
Executive Summary CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.   Asked about the US's Right to Try law, Center... Read more
November 20, 2018
FDA plans to release guidance soon that will make it easier to get a cancer companion diagnostic approved for use with an entire class of drugs, FDA Commissioner Scott Gottlieb told BioCentury.  ... Read more