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    CDRH Lays Out Guidance Plans for FY 2017

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017. The final guidance documents on the so-called “A-list” deal with some hot-button issues, including the use of real world evidence (which is also included on CDRH’s top 10 list of science priorities for 2017) to support medical device regulato...
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    FDA Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions

    The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry with 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations. The recommendations, which have been released on an ongoing basis since 2010, provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). The new guidance is for the following activ...
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    FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation

    The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing failures of the hospitals to report medical device-related adverse events. Several high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital , for their failure to keep written medical device reporting procedures and to repo...
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    FDA Offers First Major Update to ‘Orange Book’ Website

    The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.” FDA's Orange Book is widely used in the regulatory community (and by doctors) for identifying which drug products are substitutable for one another, while FDA's Purple Book is list of all licensed biologics and biosimilars (the biological equivalent of the phar...
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    Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents

    Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s known as the “on sale” bar, according to an opinion released Monday from the US Court of Appeals for the Federal Circuit. The opinion hinges on an important concept linked to the patenting of pharmaceuticals, the use of CMOs and the manufacturing processes necessary to produce pharma...
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    Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn

    The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness. The guidance focuses on a problem that has long plagued the generic industry, as generic labels are required by law to mirror their reference product counterparts at the time of approval but s...
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    European Regulatory Roundup: EMA to Waive Some Scientific Advice Fees for Accelerated Access Program (9 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts new Guidance on Changing Risk-Management Plans, Manufacturing Sites The European Medicines Agency (EMA) has posted new guidance on post-authorization changes to risk-management plans (RMPs) and manufacturing sites. EMA, which has adopted the policies in an attempt to simplify processes for marketing authorization holders, explained the implications of the guidance...
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    FDA Withdraws NDA for Fertility Drug After EMD Serono Fails to Run Postmarket Trial

    More than 10 years since the US Food and Drug Administration (FDA) offered accelerated approval to EMD Serono’s fertility drug Luveris (lutropin alpha for injection), the agency on Monday announced it’s withdrawing the drug’s approval as the company failed to run a postmarketing study required as a condition of approval. First approved on 8 October 2004, Luveris was indicated for concomitant administration with one of EMD Serono’s other fertility treatments, Gonal-F (fol...
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    FDA Warns Indian Pharma Company Over Repeat Data Manipulation Violations

    The US Food and Drug Administration (FDA) has warned India-based Emcure Pharmaceuticals for repeated data manipulation and falsification. The warning letter, issued 3 March, follows an inspection at the company’s Hinjwadi-based site from 27 January to 4 February. The site has been banned from shipping products to the US since July 2015. Back in 2014, Emcure said it would hire a third-party auditor to conduct a comprehensive audit of all laboratory electronic and hard co...
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    Indian Regulators, Medical Device Associations Focus on New Guidelines, Increasing Exports

    India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations. According to the minutes of the meeting, most of the discussion centered on increasing device exports and evaluating new guidance for industry. Draft guidance on good manufactu...
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    How Often Does FDA Withdraw Drugs Using Discontinuation Petitions? Very Rarely

    Not all drugs approved by the US Food and Drug Administration (FDA) stand the test of time. In some cases, the drugs are eventually removed from the market, either because they are unsafe, ineffective or just because their sponsor no longer feels like making them. But how often do these withdrawals take place, and to what extent do they reflect concerns about the safety or efficacy of a drug? Background The question is the subject of a new analysis by Hyman, Phelps & Mc...
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    FDA Withdraws 47 'Outdated' Guidance Documents

    Forty-seven of the US Food and Drug Administration's (FDA) guidance documents were officially declared defunct today after regulators called them unfinished and outdated. The guidance documents were eliminated in a 5 May 2015 Federal Register notice, Withdrawal of Guidance Published Before December 31, 2013 . The problem, FDA explains in the Register notice, is one of transparency and resources. Under FDA's Good Guidance Practices (GGPs), the agency is requ...