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  • Regulatory NewsRegulatory News

    Two Gene Therapy Approvals Headline CBER’s FY 2018 Report

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Wednesday published its Fiscal Year 2018 report, highlighting two gene therapy approvals, as well as the approvals of a hepatitis B vaccine, a vaccine to prevent shingles and a flu vaccine for children as young as six months. Both of the gene therapy approvals occurred at the very beginning of the previous fiscal year, with CBER signing off on Spark Therapeutics’ Luxturna...
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    Asia Regulatory Roundup: Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository   Singapore’s Health Sciences Authority (HSA) has apologized to blood donors after a vendor stored their information in a vulnerable database. HSA learned the database lacked adequate safeguards from a cybersecurity expert and does not think other unauthorized people accessed the information...
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    European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU GMP Inspectors Issued Non-Compliance Statements to 11% of Indian Sites Visited in 2016 Authorities in the European Economic Area (EEA) issued non-compliance statements to 11% of the Indian drug manufacturing plants they inspected in 2016. The rate of non-compliance is far higher than the 1% recorded globally in 2016 and the 4-6% level seen in India in the three prev...
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    FDA Offers 2016 Report on Medical Countermeasure Activities

    As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities. With a budget of a little more than $110 million, FDA’s MCM efforts play a  critical role  in protecting the US from dangerous threats and emerging infectious disease threats, such as pand...
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    Asia Regulatory Roundup: India Considers Phasing Out Gelatin-Based Capsules (12 April 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Seeks Feedback on Proposal to Phase Out Gelatin-Based Capsules The Drug Controller General of India (DCGI) is seeking feedback on a proposal to replace gelatin with cellulose in drug capsules. If enforced, the transition would represent a major change for the capsule manufacturing industry, the output of which is currently dominated by gelatin-based products. DCGI i...
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    FDA Chides GSK Subsidiary for Flu Vaccine Manufacturing Troubles

    A Canadian subsidiary of pharmaceutical company GlaxoSmithKline (GSK) has been accused by the US Food and Drug Administration (FDA) of deviating from good manufacturing practice (GMP) regulations while manufacturing the flu vaccine FluLaval . The allegations, contained in a Warning Letter released by FDA on 24 June 2014, stem from a 31 March-9 April 2014 inspection of ID Biomedical Corporation's—a GSK subsidiary since 2005—Quebec facility. The bulk of the allegati...
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    FDA Proposes Strengthening Requirements for Rapid Flu Tests

    US Food and Drug Administration (FDA) regulators are proposing to reclassify some Influenza Antigen Detection Test Systems into a higher-risk category than the systems now inhabit, citing potential for the devices to fail to detect newer versions of the virus. Background The devices, which are used to detect the presence of influenza in a clinical sample, were Classified as low-risk Class I medical devices in 1982. Class I devices only require the company to adhere to g...
  • In Midst of Crackdown, New Batch of FDA, FTC Warning Letters Target Unapproved Flu Products

    The US Food and Drug Administration (FDA) has released a bevy of new warning letters all aimed at "unapproved flu products," part of a recent crackdown by the agency on products it deems to be either ineffective or potentially dangerous. Background The 2012/2013 flu season has been a particularly strong one in the US, and high public demand for flu vaccinations has put FDA on edge, and for good reason: The combination of drug shortages and public concern is a potent rec...
  • Diploma Mill Peddled Homeopathy Product as Flu Prevention Method, FDA Claims

    US regulators frequently send warning letters to all sorts of companies for alleged violations and deficiencies; everyone from drug and device manufacturers, to institutional review boards, to small supplement manufacturers. But rarely, as the US Food and Drug Administration (FDA) did last week, do they send one regarding homeopathy products or to an online diploma mill-an unusual combination if there ever was one. Background Homeopathic products are usually just wate...
  • Rare Multi-Agency Warning Letter Slams Flu Product

    The US Food and Drug Administration (FDA) has issued a rare multi-agency warning letter to a marketer of a product claiming to give patients protection against the influenza virus. The letter, sent on 24 January 2013 to Flu and Cold Defense LLC ('FCD'), was sent in conjunction with the Federal Trade Commission (FTC). Both FDA and FTC regularly work together on matters related to advertising, but the joint warning letter is extraordinarily rare, as FTC ordinarily defers...
  • FDA Approves New Flu Vaccine with Potential Biodefense Applications

    The US Food and Drug Administration (FDA) has announced the approval of a new type of flu vaccine that provides an alternate option to those unable to consume egg-based products. The new vaccine, Flublok, is a trivalent influenza vaccine manufactured by Meriden, CT-based Protein Sciences Corporation. Unlike other flu vaccines, which utilize a live virus to infect chicken eggs, Flublok is made from only a single hemagglutinin protein from the influenza virus. That prote...
  • Italian, Swiss, Spanish Regulators Ban Sale of Novartis Flu Vaccines

    • 26 October 2012
    Two influenza vaccines manufactured by Novartis, a Swiss pharmaceutical company, have seen their marketing privileges temporarily revoked in at least three European countries this week as regulators expressed concerns regarding contamination and possible adverse side effects. The vaccines-Agrippal and Flaud-were first banned by the Italian Health Ministry after the Italian Pharmaceutical Agency (AIFA) said it was aware of the, "Presence of a protein aggregation phenome...