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In an open letter on Wednesday to his Republican counterpart on the House Committee on Oversight and Reform, Chairman Elijah Cummings (D-Md.) said he will give drugmakers the committee’s protocol for guarding their potentially sensitive internal documents. Read More
Acting FDA Commissioner Ned Sharpless addressed his agency on Tuesday for the first time and promised to focus on improving their work environment. Read More
Canadian regulators on Tuesday laid out guidance that they hope will help sponsors use real-world evidence to speed life-saving drugs to those who need them most. Read More
The Supreme Court has scotched Allergan’s attempt to hide a patent for one of its blockbuster drugs in a Native Tribe’s reservation—but the case is only different in degree from what has become common practice in the drug industry, a legal expert tells FDAnews. Read More