• Regulatory NewsRegulatory News

    New FDA Guidance for First Responders as Track-and-Trace Requirements Take Effect

    Beginning Tuesday, the delayed implementation of product tracing requirements for pharmacies will take effect, and the US Food and Drug Administration (FDA) on Monday issued final guidance saying it will not take action against first responders who fail to obtain tracing information. Background On 27 November 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law, putting forth new definitions and requirements related to pharmaceutical product tracking and...
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    Asia Regulatory Roundup: India Pushes Back Track and Trace Deadline Again (12 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Moves Back Deadline for Implementation of Track and Trace India has pushed back the deadline by which manufacturers must comply with aspects of its system to track and trace drug exports. Having originally set a deadline of July 2015, the government has now once again delayed the date on which the export monitoring system must be implemented. The Directorate Genera...
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    Asia Regulatory Roundup: China Looks to Revamp Drug Approval Process (3 November 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Proposes Drug Approval Reforms to Encourage Innovation Senior Chinese officials are considering adopting legislation that would overhaul the drug evaluation and approval process in the country to encourage innovation by incentivizing research. As it stands, only manufacturers can apply for drug approvals in China. Officials are now considering whether this disincen...
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    Studies Raise New Concerns Over FDA's Expedited Approval Designations, Supplemental Indications

    An increasing number of newly-approved drugs by the US Food and Drug Administration (FDA) have been associated with expedited development or review programs, though many of these approved drugs are not first in class and potentially less innovative, according to two new studies published in the British Medical Journal (BMJ). Background Under the standard regulatory review process, FDA has 10 months to review a potential new drug's safety and efficacy based on a company'...
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    What Causes Variations in Review at CDER? It's All About the Designation

    Last year, a study by the Manhattan Institute for Policy Research (MIPR) found variations in review time at the US Food and Drug Administration's (FDA) various drug review divisions were caused by inefficiencies at the agency. Now, FDA representatives are making the case that the variation in review times can be explained by the proportion of applications receiving accelerated review in different therapeutic areas. The MIPR study concluded that the variations in rev...
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    FDA Gives Pharmacies Another Four Months to Comply With Track and Trace Requirements

    • 30 June 2015
    The US Food and Drug Administration (FDA) plans to give drug dispensers—i.e. pharmacies—an additional four months to comply with federal track and trace requirements established under the Drug Supply Chain Security Act (DSCSA) . Background In 2013, the Drug Quality and Security Act (DQSA) was signed into law. While the DQSA is perhaps better known for its extensive pharmaceutical compounding reform provisions, it also contains another major component formally known a...
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    India Says Other Regulators Will Have Access to Export Database

    India is planning to make a database used to track drug exports available to regulators and companies around the world, The Economic Times reports. Background In recent years, India has faced allegations that manufacturers within its borders are producing and distributing spurious and counterfeit drugs. In response to these allegations, in 2009 the Central Drugs Standard Control Organisation (CDSCO) launched a survey to determine the extent of the country's spuriou...
  • Feature ArticlesFeature Articles

    Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

    In recent years, the US Food and Drug Administration (FDA) has made great advances in the review of new drugs. The US now is reported to lead the world in both timeliness and quantity of noteworthy new drug approvals. 1 This trend is due in part to FDA’s ongoing commitment to improve the drug development process and establish robust, efficient and predictable development programs. As a result, products demonstrating a positive benefit-risk profile and appropriate e...
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    FDA’s Expedited Programs for Serious Conditions: An Overview

    For some serious or life-threatening diseases, few therapeutic options exist. Once a promising therapy is discovered, establishing its clinical benefit and safety profile is necessary but can be time consuming. Standard drug development programs involve formulating and manufacturing the drug product, characterizing the new drug, gathering adequate evidence on its performance, evaluating the safety risks and confirming the effects observed in the early clinical trial...
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    Too Fast, or Too Slow? Public Disagrees Over Pace of FDA's New Drug Approvals

    According to a new survey, the US Food and Drug Administration (FDA) is in a lose-lose situation when it comes to regulating healthcare products. FDA's Lose-Lose Proposition The poll, sponsored by research advocacy group Research!America and conducted with help from Zogby Analytics, polled approximately 1,000 adults about their views on America's role in public health research and development. The research indicates, for example, that Americans are broadly in favor of ...
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    Anvisa Demonstrates New Drug Tracking Platform

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Anvisa has unveiled Brazil's first drug tracking platform - a step in the implementation of the National Drug Control System (SNCM) - providing an interface between the agency and the holders of drug registrations. The system was demonstrated on 8 October 2014 on the pr...
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    Bill Would Close Loopholes Now Preventing Some Generic Drugs From Being Approved

    A new bill introduced last week would seek to limit the use of safety programs required by the US Food and Drug Administration (FDA) to delay and even prevent the introduction of generic drugs into the market. Background REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA) , and were meant to act as a regulatory hedge against potentially risky products. REMS typically include the following elements: A communication plan, Medicat...