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    CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics

    The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children. According to CTTI, a public-private partnership aimed at improving the quality and efficacy of clinical trials, challenges in enrolling and completing pediatric clinical trials for antibiotics leads to a situation where such drugs are used in children despite lacking adequate labeling for pediatric populations. Furthermore, ...
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    21st Century Cures: Shifting the Balance of Negotiating Power

    The new 21st Century Cures law has proven to be divisive, with both advocates and critics getting hyperbolic on the law’s potential impact on the drug and medical device industries, as well as on the US Food and Drug Administration (FDA). Critics have said, among other things, that the law will forever tarnish FDA’s ability to keep dangerous new drugs and devices from hitting the market, while advocates believe it will open the US to new cures, particularly for rare dise...
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    2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning

    Turn back the clock to late October and those first 10 months of 2016 look like a relatively commonplace year for the pharma and medical device industries and their US regulatory counterpart, the US Food and Drug Administration (FDA) (on the EU side, Brexit was already causing headaches for the European Medicines Agency (EMA) as early as June). On the positive side: Agreements on the reauthorizations for each of the user fee bills that will help fund FDA for the next...
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    'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017

    The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday at the FDA/CMS Summit in Washington, DC, that she's looking to develop a plan to automate processes for new drug reviews, implement provisions of the 21st Century Cures Act and support the reauthorization of the user fee acts in 2017. 21st Century Cures On Tuesday, President Obama signed the 21st Century Cures Act into law, ushering forth...
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    FDA, NIH Unveil Initial Framework for Biomarker Qualification

    Officials from the US Food and Drug Administration (FDA), the Foundation for the National Institutes of Health (NIH) and other stakeholders, including experts from Genentech, Merck, Pfizer and Takeda, have released a framework for proposed evidentiary criteria to support the regulatory acceptance of biomarker use in drug development programs. The framework, released 6 December, is expected to help support FDA in the development of relevant guidance(s) for evidentiary cr...
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    FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’

    Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible." Defining RWE Rachel Sherman, deputy commissioner for medical products and tobacco in the Office of the Commissioner at FDA, wr...
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    Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns

    The Senate on Wednesday passed the 21st Century Cures Act by a vote of 94-5. President Barack Obama praised the bipartisan efforts and said he will sign the bill. The bill’s path to success, following the House’s positive vote last week, took a unique route, with the House also passing a previous iteration back in July 2015, and then the Senate trying to craft its own package of bills, which stalled and looked to be dead as recently as September. The wide-ranging, nea...
  • Leahy Looks to Amend ‘Cures’ Bill as Senate Prepares for Passage

    Sen. Patrick Leahy (D-VT) on Tuesday proposed an amendment to the 21st Century Cures bill that would make it more difficult for brand name drugmakers to halt or delay generic or biosimilar competition. The amendment, supported by the Generic Pharmaceutical Association on Tuesday, would promote competition by further encouraging manufacturers to share product samples with generic and biosimilar companies so that more of these lower-cost treatments can be approved by th...
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    House to Pass Revamped 21st Century Cures Bill

    The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding. The 996-page bill, known as the 21st Century Cures bill  and released last Friday, has already earned praise from the White House and is likely to pass the Senate, which will take it up early next week. In addition to speeding up the approvals of new drugs, devices...
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    Regulatory NewsRegulatory News

    Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA

    Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it. The 996-page bill includes major tweaks to the way in which the US Food and Drug Administration (FDA) regulates drugs, devices and biologics, while providing the agency with $500 million over 10 years to implement provisions that seek to move such products to patients more qu...
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    A ‘Cures’ Revival? Congress Looks to Lame Duck Session to Pass Bill Overhauling FDA, NIH

    With the election just eight days away, House and Senate Republicans are working hard to re-shape a wide-ranging bill lingering for more than two years that would overhaul the way the US Food and Drug Administration (FDA) reviews medical devices and significantly increase (to the tune of almost $9 billion over five years) funding for the National Institutes of Health (NIH), among other major changes. Last month, Senate Majority Leader Mitch McConnell (R-KY) and House Spe...
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    Senate Pushes Work on ‘Cures’ Legislation Back to September

    The Senate’s version of the House-passed 21st Century Cures bill will not be finished until after the Senate’s summer recess, or September at the earliest, Sen. Lamar Alexander (R-TN) said, confirming rumors that the Senate was struggling to reach agreement on the wide-ranging and heavily criticized legislation. “Rarely do we have such an opportunity: it includes support for the President’s Precision Medicine initiative and the Vice President’s Cancer Moonshot. Speaker [...