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  • Regulatory NewsRegulatory News

    FDA Proposes to Remove Mycoplasma Test Method

    The US Food and Drug Administration (FDA) issued a proposed rule on Monday to remove the required testing method to detect the presence of Mycoplasma because FDA said the regulation is restrictive in that it identifies only one test method to be used even though other methods may be appropriate. The proposed rule seeks to remove the testing method for Mycoplasma detection in virus harvest pools and control fluid pools of live and inactivated virus vaccines produced ...
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    FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization

    For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence. Antimicrobial resistance has been recognized as a public health threat. The World Health Organization said it is "so serious that it threatens the achiev...
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    Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Offers Fast-Track Approvals to HIV, Hepatitis Combination Products The Drug Controller General of India (DCGI) is offering fast-track approvals to combination products to treat HIV and hepatitis B and C. DCGI Dr GN Singh is prepared to waive the need to run clinical trials and truncate the regulatory submission process to cut the time it takes for sponsors to br...
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    GAO: Drugmakers Want More Clarity on Antibiotic Incentives

    Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO). Specifically, GAO says that FDA has issued 14 updated or new guidances focused on antibiotics since the Generating Antibiotic Incentives Now (GAIN) Act was passed as part of the Food and Drug Admi...
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    European Regulatory Roundup: EMA Plans Ways to Curb Antibiotic Resistance (2 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Proposes Restricting Use of Colistin to Curb Rise of Antibiotic Resistance The European Medicines Agency (EMA) is proposing to restrict the use of colistin to curb the rise of antibiotic resistance. Under the plan, use of colistin in animals would be limited to last-resort cases, a constraint intended to quell concerns that an emerging resistant mutation will spread quic...
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    European Regulatory Roundup: Brexit Could Lead to New Regulatory Burdens (25 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Industry Leaders Warn Brexit Would Lead to Significant Regulatory Burdens More than 50 leaders of the British biopharmaceutical industry have warned of the regulatory and business upheaval that could result from the United Kingdom leaving the European Union, an event dubbed “Brexit.” In a letter in The Financial Times , the executives argue leaving the EU would result in “s...
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    EMA to Investigate Use of Last-Resort Antibiotic

    The European Medicines Agency (EMA) announced Monday that it will investigate the use of a last-resort antibiotic after the discovery of a gene in the EU that causes bacteria, such as E. coli , to become resistant to the drug. Background In November, scientists published a study in The Lancet on the gene, known as MCR-1, which was found to cause bacteria to become resistant to the last-resort antibiotic, known as colistin, which is of the polymyxin class and can be...
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    FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

    In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS). Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Orga...
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    As US Falters in Fight Against Antibiotics Over-Prescribing, EU Makes Progress

    The European Union seems to be making substantial strides in something the US thus far has been unable to do: reducing the use of antibiotics in food-producing animals. In a new report issued on 15 October 2014, the European Medicines Agency (EMA)—the EU's version of the US Food and Drug Administration (FDA)—announced that between 2010 and 2012, the sales of antibiotics for use in animals fell 15% on average across 20 European countries. While some of those countries...
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    US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

    A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends. Background The report , authored by the President's Council of Advisors on Science and Technology (PCAST) and released on 18 September 2014, comes just as two troubling trends are intersecting. The first: Antibiotic resistance, which government officials blame for ...
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    FDA Gonorrhea Guidance Follows Now-Familiar Framework on Antibiotic Development

    The US Food and Drug Administration (FDA) has published a new draft guidance on the development of antibacterial drugs intended to treat "uncomplicated" gonorrhea, the latest in a string of guidance documents reflecting the agency's new thinking on antibiotic development. Background In the last few years, FDA has released a bevy of guidance documents aimed at making it easier for companies to develop antibiotic products by easing requirements around clinical trials...
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    FDA Adds Three New Pathogens to GAIN Act Qualifying List, But Impact Remains Unclear

    The US Food and Drug Administration (FDA) has released an updated and final list of pathogens that are eligible for special incentives under the 2012 Generating Antibiotics Incentives Now (GAIN) provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) . Background The GAIN Act was passed in an attempt to incentivize the development of new antibiotics—a response to both growing rates of microbial resistance to antibiotics and a dearth of...