• Regulatory NewsRegulatory News

    EMA Recommends First All-Oral Treatment for Sleeping Sickness

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it has adopted a positive scientific opinion of Fexinidazole Winthrop (fexinidazole), the first oral-only medicine for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness.   This approval is a result of clinical trials led by the non-profit research and development organization DNDi, with an application submitted to EMA b...
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    PMA Denials: Why so Few?

    In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified that the company has received such a letter. But in the world of medical devices, failing to win approval for a high-risk device is a much more closely held secret, and companies can withdraw their applications rather than be denied approval.   A Federal Register notice ...
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    Novartis Calls for FDA Enforcement Against Biosimilar Misinformation

    Building off a Pfizer citizen petition on biosimilar misinformation, Novartis is calling on FDA to set the record straight on what information can be disseminated. The misinformation campaigns, as explained in Pfizer’s petition from August, “further demonstrate efforts to foster fear and highlight hypothetical yet unproven risks associated with the use of FDA-approved biosimilars,” Novartis said. Amgen, Genentech and others are called out for these campaigns that n...
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    Water Quality for Pharmaceutical Use: EMA Opens Consultation

    With the aim of replacing guidance from 2002 on quality of water for pharmaceutical use, the European Medicines Agency (EMA) is offering new draft guidance for industry on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use. EMA says the guidance should be considered for those submitting new marketing authorization applications (MAAs), as well as any variant applications to exist...
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    Pazdur, Marks and Woodcock Discuss FDA Changes, What’s Coming

    Three of the US Food and Drug Administration’s (FDA) directors – Richard Pazdur, Peter Marks and Janet Woodcock – took the stage Wednesday at Prevision Policy’s Biopharma Congress to discuss all things FDA – from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers. Center for Drug Evaluation and Research Director Woodcock said that the difference between years past, when FDA was viewed negatively, and now is tha...
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    Woodcock Pushes for Major Digital Shift in Regulation

    Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, made clear on Tuesday that there needs to be a major shift in regulatory toward a more digital world. “The time has come that we think about digital tech in a new way to streamline and use the digital age to effectively regulate and efficiently regulate,” Woodcock said at the Friends of Cancer Research annual meeting Tuesday. She noted that regulators arou...
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    FDA Begins Updating Generic Chemotherapy Labels

    As part of efforts to ensure older generic drug labels remain relevant, the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) has begun updating generic chemotherapy labels. Speaking at Friends of Cancer Research’s annual meeting on Tuesday, FDA Office of Hematology and Oncology Products (OHOP) Supervisory Associate Director Amy McKee explained the push to update the labels, known as Project Renewal, which will update about 40 generic chemother...
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    Review Addresses Obstacles to US Biosimilar Entry and Uptake

    Although 14 biosimilars have now been approved by the US Food and Drug Administration (FDA), only six have reached the market and questions about the viability of the biosimilar industry in the US have been raised. According to a review published by Ameet Sarpatwari and others from the Department of Medicine at Brigham and Women's Hospital and Harvard Medical School in Clinical Pharmacology & Therapeutics , there are several steps FDA and lawmakers can take to ensure t...
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    FDA Hits Monthly Generic Drug Approval Record in October

    With 110 approvals and 18 tentative approvals, the US Food and Drug Administration (FDA) approved more generic drugs in October than any month prior. The 128 total approvals barely edged the 126 total approvals from July 2018. The next closest month was November 2017, with 107 total approvals. The 128 total also included 23 first generic drug approvals (i.e. for brands that lacked competition) and 17 complex generics. The record month in October follows a record year...
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    France Begins Speeding Clinical Trial Start-Up Times

    As part of a push to more quickly offer patients access to innovative treatments, France’s drug regulator, known as ANSM, has established two “Fast Track” options that will expedite the authorization of clinical trials. Unlike the US Food and Drug Administration’s (FDA) Fast Track process, which is designed to expedite the review of drugs to treat serious conditions and fill an unmet medical need, France’s new designation concerns clinical trials of innovative treatment...
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    FDA Looks to Modernize Sterile Injectable Inspections

    With an eye toward averting drug shortages and sterility question marks, the US Food and Drug Administration (FDA) is modernizing its inspections program with a new way of assessing, recording and reporting data from surveillance and pre-approval inspections for sterile drugs. The New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a more structured manner for more consistent facility oversight and faster and more ...
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    EMA Revises Guidance on Publication of Clinical Trials Policy

    The European Medicines Agency on Friday offered a look at the major and minor changes made to guidance on the agency’s policy on the publication of clinical data for medicinal products for human use.   The policy, known as “Policy 0070,” was adopted by the EMA Management Board on 2 October 2014 and is composed of two phases. Phase 1 entered into force on 1 January 2015 and pertains to publication of clinical reports while Phase 2, which will be implemented “at a later ...