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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 Offers Recommendations on Highlights Section of Labeling

    The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics. Specifically, the guidance details the content and format of the Product Title and Initial US Approval subsections within the Highlights of Prescribing Information for newly approved drugs and drugs with labels being revised. In 2006, FDA's final rule on the conten...
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    ABPI Extends Astellas UK Suspension for 12 More Months

    The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety." Astellas was originally suspended in June 2016 for deception and was re-audited in September 2016 and April 2017, which "highlighted a lack of oversight and training of agency nurses who delivered patient support programmes, inc...
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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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    New Report Investigates Drivers of Off-Label Prescribing in the EU

    A lack of incentives to go through the marketing authorization process to extend certain drug labels, as well as pricing and reimbursement issues, were cited as some of the varied drivers of off-label prescription drug use in the EU, according to a new report from the European Commission. “Data from scientific literature reveal that the prevalence of off-label use in the EU within the paediatric population is generally high, covers a broad range of therapeutic areas and...
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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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    FDA Proposal Calls for Drug Labeling to be Distributed to Doctors Electronically

    In a long-anticipated and major move, the US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically. Background The proposed rule , Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products , comes after years of development at FDA. Under Section 1140 of the 2012 Food and Drug Administratio...