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The International Council on Harmonization is proposing to expand guidance concerning data quality, medication errors and product issues by developing a more detailed companion document that would include Q&A sections and more examples. Read More
A group of 31 Democratic senators have asked Kaléo to provide details on pricing of the company’s opioid overdose treatment Evzio, requesting documents on production costs and donation programs. Read More
FDA medical officers — including those involved with product review and post-market safety monitoring across CDER, CBER and CDRH — will be exempt from the federal hiring freeze, according to an HHS memo. Read More
The FDA’s Office of Generic Drugs received 57 ANDAs in January, marking a nearly 76 percent decrease in submissions from the previous month, when the agency experienced a surge in applications. Read More
The Trump administration is being sued over the president’s executive order requiring federal agencies to cut two regulations for every one they issue. Read More
The HHS secretary recently delivered FDA’s recommendations for reauthorizing user fees covering prescriptions, generic drugs and biosimilars to Congress, before the body begins to craft a legislation package due by the end of September. Read More