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A European Medicines Agency report states that 944 API manufacturers were inspected in the first six years of the International Active Pharmaceutical Ingredient Inspection Program. Read More
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Read More
Participants in the discussion will include the directors of advocacy groups, recovering addicts and those who have lost family members to addiction. Read More
Sen. Hatch said the bill would cut red tape to ensure manufacturers of non-opioid pain medications can bring them to market as quickly as possible. Read More
In the latest addition to the swirl of opioid-related bills circulating on Capitol Hill, four senators introduced legislation to require the FDA to issue guidance on how breakthrough and accelerated approval designations apply to novel, non-opioid or non-addictive pain medications. Read More
Disease-focused guidance and a new knowledge management platform are among the key initiatives in the FDA’s fiscal 2019 budget request of $5.8 billion, Commissioner Scott Gottlieb told the House Appropriations Committee on Tuesday. Read More
The committee has been investigating the activities of drug wholesalers who are legally required to report suspicious orders of opioids to the Drug Enforcement Agency. Read More
Judge Dana Christensen of the U.S. District Court for the District of Montana sentenced the company’s founder, Kris Thorkelson to six months' house arrest, five years' probation and a $250,000 fine. Read More
Moves to increase clinical trial data transparency gathered momentum this week with the release by Vivli of the beta version of its clinical trial data-sharing platform to the public prior its full rollout on July 19. Read More