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  • Regulatory NewsRegulatory News

    WHO to Craft Essential Diagnostics List

    The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL). The committee said the decision to begin developing such a list, agreed to earlier this month, may initially focus on in vitro diagnostics, with initial proposed priority areas including tuberculosis, malaria, HIV and hepatitis B and C. According to WHO , the list "should expand to other areas including other antimicrobial...
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    WHO Essential Medicines Update Adds Antibiotic use Framework and new HCV & HIV Drugs

    The World Health Organization (WHO) on Tuesday announced updates to its essential medicines list (EML), including new recommendations for antibiotic use and the addition of new drugs to treat hepatitis C, HIV and leukemia. The list, which is intended to serve as a model for the most crucial medicines for ensuring public health, is updated every other year based on recommendations from WHO's Expert Committee on the Selection and Use of Essential Medicines. "These medicin...
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    Top Ten Stories From 2016 by Traffic

    Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading! Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers : A perennial favorite, this explainer breaks down the latest in the lucrative world of PRVs. Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017 :...
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    FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

    The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list. If the proposed rule is finalized, the six bulk drug substances proposed for inclusion will be the first to be included on what’s known as the 503A bulks list. FDA’s Pharmacy Compoundi...
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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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    Updated Again: FDA to Pull Singapore Device Firm From Import Alert List

    A subsidiary of Biosensors International, a group of companies developing, manufacturing and marketing medical devices for cardiology and critical care procedures, failed to respond to an inspection request from the US Food and Drug Administration (FDA) and its products were banned from entering the US. However, five days after the company's name was posted on the import alert list, a Biosensors spokesman told  Focus  that the company will be removed from the list aft...
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    Cancer Gene Therapies: FDA Officials Highlight Regulatory Approaches

    As gene therapies begin to get a foothold among other cancer treatments, the US Food and Drug Administration (FDA) is taking a more flexible, data-driven approach for the preclinical testing programs of these biologically complex products, according to a new review from five FDA officials in Cancer Gene Therapy . Although FDA has yet to approve a gene therapy to treat cancer, the authors note that about two-thirds of gene therapy clinical trials are for cancer treatment...
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    FDA Bans Pharma, Nutraceutical and Cosmetic Imports from Canadian Company

    The US Food and Drug Administration (FDA) has added Canada's Cosmetic Manufacturers Inc. (CMI) to a list of companies that have been banned from shipping products to the US. CMI manufactures cosmeceuticals, nutraceuticals and pharmaceuticals, including a digestive enzyme therapy, according to its website . The company says it has a Drug Establishment License and owns the rights to many Drug Identification Number products under the CMI name. The updated FDA import alert...
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    FDA Warning Letter Details Serious Violations by another Indian API Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released another Warning Letter for an Active Pharmaceutical Ingredient (API) and drug manufacturer in India with a series of severe findings. The most recent letter sent to Gujarat, India-based Pan Drugs, which is already barred from supplying drugs and APIs to the US, follows the identification of more Current Good Manufacturing Practices (CGMP) violations by FDA inspectors, including data integrity issues, as well a...
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    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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    TrackersTrackers

    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...