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  • Regulatory NewsRegulatory News

    India Looks to Cap Prices of 12 Cancer Drugs as Nation Looks to Expand Price Controls

    The cost of 12 cancer drugs could soon be capped in India if a recommendation from the country's National Pharmaceutical Pricing Authority (NPPA) is approved, The Indian Express reports. At the same time, the government is actively looking into revising its National List of Essential Medicines (NLEM) following a proposal from a parliamentary committee for price caps to be extended to all drugs two weeks ago. Background In India, the prices of drugs listed under t...
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    The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech

    Let's face it: Finding regulatory information can be difficult. Maddeningly difficult. Anyone interested in finding information about the US Food and Drug Administration (FDA) needs to have an almost encyclopedic knowledge of the regulator's website to find relevant information, to say nothing of the dozens of other government websites which house regulatory information or non-governmental websites which make finding information easier. What if there were an easier way t...
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    Small Regulation: FDA Adopts Three Nanotechnology Standards in Last Year

    The US Food and Drug Administration (FDA) has just adopted a new standard on the use of nanotechnology in medical devices—only its third nanotechnology standard yet adopted. Background The new standard, Surface Characterization Of Gold Nanoparticles For Nanomaterial Specific Toxicity Screening: FT-IR Method , was released on 27 January 2015 as part of a major update to FDA's List of Recognized Standards . The standards adopted by FDA are something of a deviation from...
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    EMA Issues Guidance on Clarification Meetings

    The European Medicines Agency (EMA) is looking to increase transparency between its committees and pharmaceutical companies under a new guideline that went into effect in February 2015. The guideline, EMA/636600/2014, details procedures regarding clarification meetings in response to questions raised by the agency during the review of a product using the centralized procedure. Clarifying Objections EMA believes increasing transparency between the agency and applicant...
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    FDA Bans Drugs Made by Indian Manufacturer Over GMP Problems

    US medicines regulators have quietly banned drugs manufactured at a facility owned by Ipca Laboratories, an Indian pharmaceutical manufacturer, from entering into the US after finding that its products were not manufactured to federal standards. On Thursday, 22 January 2015 the US Food and Drug Administration (FDA) issued an update to its Import Alert 66-40, which is used to warn US customs officials that a company's products have not met good manufacturing practices (GM...
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    FDA Appoints Members to New, Influential Advisory Committee

    Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector. Background The re-creation of the PCAC was called for under the Drug Quality and Security Act (DQSA) , which sought to update the way in which FDA regulated p...
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    FDA Finalizes Policy to Cut Down on Suspicious Behavior During Facility Inspections

    The US Food and Drug Administration (FDA) has put the finishing touches on a new policy intended to ensure the companies it regulates aren't able to hide problems from it during the course of inspections. Background In July 2013, FDA released a draft guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection seeking to clarify its newfound authority under the Food and Drug Administration Safety and Innovation Act (FD...
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    Chinese Company Used Suppliers Linked to Contaminated Heparin Scandal, FDA Claims

    A Chinese-based manufacturer of heparin products has been sent a Warning Letter by the US Food and Drug Administration (FDA) after regulators accused the company of preventing FDA inspectors from accessing the facility earlier this year, and possibly manufacturing contaminated products. Background In its 29 September 2014 Warning Letter to Beijing Shunxin Meihua Bio-technical Co., Ltd, FDA said its inspectors were unable to access the majority of the company's Beijing...
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    DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

    US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA) , establishing the quantities of the drugs which may be produced in 2015. Quota Adjustments In a 5 September 2014 Federal Register notice , the US Drug Enforcement Administration (DEA), which is charged with setting the quotas, released a list of dozens of schedule I and II controlled substances which will be subject to produc...
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    In FDA Effort to Strengthen Regulation of Compounded Drugs, Protections and Profits Intersect

    A new law meant to protect consumers from unsafe pharmaceutical compounding practices is drawing interest from pharmaceutical companies, who are petitioning the US Food and Drug Administration (FDA) to add some of their products to a new list of restricted drugs that could protect patients from deficient drugs—and likely companies from compounded competition as well. Background The Drug Quality and Security Act (DQSA) of 2013 was passed into law in the wake of a massi...
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    NIH Wants Safety, Efficacy of Viagra, Epogen and Other Drugs Tested in Children

    • 25 August 2014
    The National Institutes of Health (NIH) has released a new "Priority List" of pediatric therapeutic areas and medical products it wants the medical community—including the pharmaceutical and biopharmaceutical industries—to focus on. Background Historically, many companies seeking product approval in the US avoided clinical studies involving children, wary of ethical problems, a lack of incentives and the potential consequences if testing uncovered new problems. As a res...
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    FDA Flexes New Inspection Authority, Banning Company After it Refuses to be Inspected

    The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators. The company, Beijing Shunxin Meihua Bio-technical Co., was placed on import alert by FDA on 22 July 2014. FDA's import alerts—one for refusing inspection , and the other for failing to operate according to good manufacturing practi...