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In a rare warning letter to an institutional review board, CDER’s Office of Scientific Investigations contends that an IRB at Monmouth Medical Center was lax in supervising research at the facility. Read More
The FDA plans to establish a system that would allow for the use of “real-world evidence” to help the agency more quickly identify safety signals and address concerns, according to its list of strategic priorities for 2016-2017. Read More
With 12 nations signing off on the Trans-Pacific Partnership on Wednesday, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More
An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support Tuesday, backing its approval for six different indications in a 21-3 vote. Read More
Republicans on the Hill already are blasting the White House’s fiscal year 2017 budget, which would give the FDA about $5.1 billion, roughly $358 million more than what the agency received last year. Read More
The European Medicines Agency and the European Commission today published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
The White House announced Monday that it plans to ask Congress for $1.8 billion in emergency funding to combat Zika, including $200 million to develop and commercialize vaccines and diagnostic tests. Read More