• Regulatory NewsRegulatory News

    New FDA Drug Approvals: Breaking Down the Numbers

    If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010. And with only 18 FDA decisions on new drugs expected in 2017, according to BioPharma Catalyst , the number of FDA approvals may continue to decline to a level the industry has not seen since 2007, when 18 new molecular entities (NMEs) and new biologic license applications (BLAs) were approved. But as John ...
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    NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage

    The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to the best new medical devices, diagnostics and other health-related technologies. FDA’s Center for Devices & Radiological Health (CDRH) initially established the PCTF to facilitate communication between device manufacturers and payers to pot...
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    Medical Device Performance Goals: FDA Offers a Quarterly Update

    The US Food and Drug Administration (FDA) on Friday released its latest performance data, revealing that the number of premarket applications (PMAs) for devices with a major deficiency letter on the first FDA review cycle is up to its highest level ever, and up more than 25% since 2015. On the approval side, FDA’s Center for Devices and Radiological Health (CDRH) continues to approve PMAs at a high rate and almost as quickly as the agency ever has. For 510(...
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    Australia’s TGA Looks to Mirror US FDA, EMA With Two New Expedited Drug Approval Pathways

    As part of an attempt to catch up with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, Australia’s Therapeutic Goods Administration (TGA) on Monday released five new consultations for public comment, including one that would forge new priority review and provisional approval pathways. TGA’s priority review pathway, like Health Canada’s and FDA's  pathway with the same name , will involve faster reviews of prescription drugs ...
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    FDA Approves First PFO Occluder From St. Jude

    The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who previously had a stroke. The device – which was marketed more than a decade ago under a humanitarian device exemption (HDE) but was voluntarily withdrawn by St. Jude in 2006 after FDA concluded that the target population for it was greater than 4,000 patients – is specifically for s...
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    China to Begin Priority Reviews of Medical Devices in January 2017

    China Food and Drug Administration (CFDA) announced Thursday that its priority review and approval procedure for medical devices will come into force as of 1 January 2017. The move is part of CFDA’s implementation of reforms to its approval systems for drugs and devices, and to meet the clinical demands of medical devices. According to the law firm Ropes & Gray , the new policy, first drafted in June, will allow applicants with a Class II device (limited to importe...
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    UK Report Calls for Streamlining to Accelerate Access to Drugs by Four Years

    The UK government on Monday released a new report on accelerated access, claiming the UK's National Health Service (NHS) could speed access to new drugs and devices by streamlining regulatory, health technology assessment (HTA) and reimbursement mechanisms. Specifically, the report proposes the development of an "accelerated access pathway" that would help speed up new technologies, including drugs, devices and diagnostics with the potential to provide significant benefi...
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    FDA Proposes to Withdraw Two Generic Versions of ADHD Drug Concerta

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday proposed withdrawing two generic versions of Janssen’s extended-release attention deficit hyperactive disorder (ADHD) drug Concerta (methylphenidate hydrochloride) two years after determining that they do not provide sufficient therapeutic effects. The manufacturers of the two Concerta generics - Kremers Urban Pharmaceuticals, a subsidiary of the Lannett Company, and Ma...
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    Global Regulatory Strategy

    This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers. The term "strategy," per Merriam Webster (Edition 11), means "a careful plan or method for achi...
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    Final FDA Rule Clarifies Pharma Patent Process With Aim of Reducing Unnecessary Litigation

    With the intent to cut back on the type of litigation that can delay the approval and marketing of generic drugs under 505(b)(2) applications and abbreviated new drug applications (ANDAs), the US Food and Drug Administration (FDA) on Wednesday released a final rule that revises and clarifies its regulations on a number of different parts of the pharmaceutical patent process. The 289-page final rule amends FDA’s regulations to facilitate better compliance with and enforce...
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    Sarepta Wins Controversial FDA Approval for First DMD Drug

    The US Food and Drug Administration (FDA) on Monday approved Sarepta Therapeutics’ first drug to treat patients with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness in young children. The approval is highly controversial after a FDA advisory committee voted against approval in April as the outside experts said there was not substantial evidence that the drug is effective in providing clinical benefit...
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    Japan’s Ministry of Foreign Affairs: Don’t Move EMA Headquarters From London

    If the European Medicines Agency (EMA) transfers its headquarters to another EU member state, which is all but certain following the Brexit vote, Japan’s Ministry of Foreign Affairs is warning that the “appeal of London as an environment for the development of pharmaceuticals would be lost.” The harsh critique comes as the EMA, which has 890 employees of various nationalities at its headquarters in London, has said the decision on where to move from its current locale...