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    Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Opens Door to Foreign Clinical Trial Data to Accelerate Drug Approvals China is planning to accept data generated from clinical trials run overseas. The proposal is part of a suite of changes put forward by the State Council to boost China’s support for innovative drugs and devices and accelerate their path to patients. The State Council broke its proposals up i...
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    FDA Bans Powdered Gloves

    The US Food and Drug Administration (FDA) on Friday issued a final rule banning powdered medical gloves beginning on 19 January 2017. FDA proposed the ban in March, citing mounting evidence that such gloves posed serious risks to patients, including airway and wound inflammation, post-surgical adhesions and allergic reactions. This is only the second time FDA has banned a medical device since banning prosthetic hair fibers in 1983. In April, FDA proposed banning a ...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Revised Vaccine Distribution Regulations (21 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guide to Implementing Revised Vaccine Distribution Regulations China Food and Drug Administration (CFDA) has released a guide to the implementation of its revised vaccine procurement and distribution regulations. The updated policy calls for vigilant record keeping by organizations in the supply chain and stronger regulatory oversight of each step in the pr...
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    Asia Regulatory Roundup: CFDA Revises Guidance on Device Trials (29 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Introduces Revised Guidance on Clinical Trials of Medical Devices China Food and Drug Administration (CFDA) has introduced a good clinical practice (GCP) document covering medical devices. The text describes how CFDA expects sponsors and other organizations to handle aspects of medical device trials, from the initial preparations through to the maintenance of da...
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    Asia Regulatory Roundup: India Reverses Opposition to Off-Label Ophthalmic Use of Avastin (15 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Reverses Opposition to Off-Label Ophthalmic Use of Avastin India has quickly reversed its opposition to the off-label ophthalmic use of Roche’s Avastin (bevacizumab).  Drug Controller General of India Dr. GN Singh warned against using Avastin in ophthalmology conditions in January after reports linking it to loss of vision emerged, only to withdraw the alert th...
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    FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

    • 22 May 2015
    The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week. The announcement, contained in the latest edition of the US Unified Agenda , contains 33 proposed and final rules FDA says it hopes to publish by the end of calendar year 2015. In practice, however, some rules have remained on FDA's Unified Agenda for years. FDA's latest update of the Unified contains two additional regulations compared to its las...
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    EMA Drafts New Clinical Development Guideline for Fixed Dose Combination Drugs

    In response to a rise in the use of fixed dose combination (FDC) drugs, the European Medicines Agency (EMA) has revised its guideline addressing the clinical development requirements for FDCs. Background FDCs—or drugs containing multiple active ingredients—are used to treat a variety of medical issues, ranging from the common cold to tuberculosis and HIV. For many treatments, combining multiple active ingredients can result in a simpler, more effective treatment regime...
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    When is a Drug a 'New' Drug? Legislation Seeks to Change Definition

    New legislation introduced in the US House of Representatives last week seeks to incentivize the development of new combination drugs by redefining what a "new" drug really is. Background Under existing rules administered by the US Food and Drug Administration (FDA), not all new drug products are treated the same. New chemical entities (NCEs) that have never before been approved in the US for any indication are eligible for five years of marketing exclusivity, during wh...
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    FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood. FDA's guidance documents are its interpretations of regulations and legislation, which serve to "guide" persons or companies to a state of compliance. While t...
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    New Fixed-Dose Combination Drugs Now Eligible for 5 Years of Exclusivity, FDA Says

    The US Food and Drug Administration (FDA) has finalized a new policy which will for the first time allow new fixed-dose combination  (FDC) drugs consisting of at least one new drug product to be eligible for five years of so-called "New Chemical Entity" (NCE) exclusivity. But in a setback for companies with existing FDCs, the agency will not apply the policy retroactively. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from...
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    Indian Regulators Say Older Fixed-Drug Combinations Can Stick Around Under New Rules

    India’s Central Drugs Standard Control Organization (CDSCO) has issued a notice exempting certain Fixed Dose Combination products (FDCs) from a requirement to submit data in support of safety and efficacy as long as they were licensed for marketing by State Licensing Authorities prior to 21 September 1988.   The 5 June 2014 decision to exempt these FDCs from the scope of the CDSCO’s 15 January 2013 mandate was based on the fact that the products were licensed bef...
  • FDA: State, Federal Efforts to Reduce Access to Zohydro 'Extremely Troubling'

    Since the US Food and Drug Administration (FDA) approved Zogenix's non-abuse-deterrent pure hydrocodone painkiller Zohydro ER (hydrocodone bitartrate) in October 2013, groups opposed to the drug have proposed a number of ways to overrule the agency's approval order and remove the drug from the market. Legislators have called for FDA to reconsider. They've called for the government to investigate the approval. They've called for the Department of Health and Human Services...