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Robert Califf, President Barack Obama’s choice to head the FDA, is calling for clinical trial reform, but does not believe new regulations are needed. Read More
Titan Pharmaceuticals won positive news from an FDA advisory committee Jan. 12, with panelists voting in favor of approving its implant to treat opioid addictions. Read More
Effective standard operating procedures are central to any life sciences company, but the FDA’s pharmaceutical regulations don’t mention SOPs specifically. Instead, regulations refer to “procedures” related to quality control and require them to be maintained in writing. Read More
Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices. Read More
Patent cases involving payments to delay generic competition have dropped 27 percent following a 2013 challenge to the practice, according to the Federal Trade Commission. Read More
Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for following the law. Read More
While the FDA is speeding many drugs to the market, the agency lacks reliable, accessible data needed to conduct systematic oversight and meet postmarket safety reporting responsibilities, says a GAO report released Thursday. Read More