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The FDA has pledged to delay enforcement of key elements of its new track and trace regulations for drugmakers, promising that until May 1 it will take no action against companies that do not capture and transmit product information. Read More
The European Medicines Agency released a comprehensive report detailing steps to better prevent and detect fraud and biased medical product reviews by 2016. Read More
The European Medicines Agency has chosen six drugs for initial review under its adaptive pathways pilot project, out of 34 potential candidates. Read More
Generics makers are pressing the FDA to expand its criteria for granting first-generic status to ANDAs, a move that would put more drugs in line for expedited review. Read More
Drug industry groups are urging the European Commission to invest more in research and development, streamline regulatory systems and accelerate recently approved clinical trial reforms as ways to bolster the EU’s pharmaceutical industry. Read More
Addressing the ANDA backlog, setting up the pharmaceutical quality office, and issuing final guidance on abuse-deterrent opioids are among the roughly dozen top priorities for CDER in 2015. Read More
The FDA wants everyone to know that it doesn’t have a drone program in place, nor is it exploring the technology for inspections or surveillance. Read More
Phase II trials of a much-lauded Ebola vaccine have been pushed back until at least the second week of February, after African regulators asked GlaxoSmithKline for more information about the upcoming studies. Read More
Starting next year, pharmaceutical wholesale distributors must submit annual reports that include detailed contact and state licensure information as well as any significant disciplinary actions taken by state or federal officials, the FDA says. Read More