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  • Regulatory NewsRegulatory News

    EMA Offers Q&A on Exemptions From Batch Re-Testing for Imported ATMPs

    The question and answer (Q&A) document released by the European Medicines Agency (EMA) on Wednesday describes when an exemption from EU batch re-testing can be granted for imported advanced therapy medicinal products (ATMPs). The three-page Q&A begins by noting that a Qualified Person (QP) has to ensure each batch of imported ATMP is re-tested upon importation. But the QP can certify that the imported batch relies on controls conducted in a third country if the product ...
  • Regulatory NewsRegulatory News

    EC Reiterates: All Batch Testing Must be Transferred From UK to EU by 2020

    The European Commission (EC) said recently that all marketing authorization holders (MAHs) need to ensure that all work at batch testing facilities in the UK is transferred to EU facilities and that all the necessary regulatory submissions are completed by 1 January 2020. The reminder announcement follows a letter sent last February that said drugmakers under certain circumstances would be allowed to continue batch testing in the UK even after the UK departed from the...
  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Heart Failure Treatment Endpoints

    As heart failure afflicts 6.5 million in the US, the Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s current thinking on developing drugs to treat heart failure. While noting that there are no effective treatments for heart failure with preserved ejection fraction (HFpEF), which represents about 50% of heart failure cases, FDA says up front that the 7-page draft has two purposes: to make clear that an effect on symptoms or physical...
  • Regulatory NewsRegulatory News

    European Commission and EMA Offer Guidance on Brexit for Pharma Companies

    As marketing authorisation holders (MAHs) based in the UK begin to form plans to transfer their marketing authorizations (MAs) to holders established in the EU, Norway, Iceland and Liechtenstein, the European Medicines Agency (EMA) and European Commission on Wednesday released guidance to prepare industry for the UK’s withdrawal from the EU. The question and answer document is the first in a series of guidances and follows a notice sent earlier this month to ...
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    FDA Warning Letter Reveals Data and Sterility Issues at Teva Plant in Hungary

    The US Food and Drug Administration (FDA) on Tuesday released the warning letter it sent to Israel-based Teva Pharmaceuticals earlier this month, noting instances of data deletion and manipulation at the company’s manufacturing site in Gödöllő, Hungary. Last week, Teva disclosed in an SEC filing that it had received a warning letter on 14 October (four months after the site was banned from shipping products to the US), but now the details of that letter have revealed...
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    Researchers: Patient Reported Outcomes for Heart Failure Fail to Meet FDA Criteria

    A team of researchers say that no currently available patient-reported outcomes for heart failure meet the US Food and Drug Administration's (FDA) criteria for supporting product approval. In a recently published review in the Journal of the American College of Cardiologists , the researchers checked the patient-reported outcomes against nine criteria adapted from the 14 listed in FDA's 2009 guidance, Patient-Reported Outcome Measures: Use in Medical Product Developme...
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    FDA Allows First Switch From Batch to Continuous Manufacturing for HIV Drug

    The US Food and Drug Administration (FDA) for the first time in its history allowed a manufacturer to switch from the more antiquated batch manufacturing process to a continuous manufacturing process – a move that FDA is seeking to encourage among more pharmaceutical manufacturers. The manufacturing change, announced last Friday, is for Janssen’s HIV-1 treatment Prezista (darunavir). And although Janssen isn’t the first manufacturer to use continuous manufacturing (Verte...
  • Regulatory NewsRegulatory News

    EMA Offers New Draft Guidance on Developing Treatments for Chronic Heart Failure

    The European Medicines Agency (EMA) on Thursday released new draft guidance for public consultation on the clinical development of new drugs to treat chronic heart failure (CHF). The new draft is meant to update previous guidance, known as “Note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure,” in order to differentiate the types of heart failure between reduced and preserved ejection fraction, call for companies to inclu...
  • FDA Presses BMS to Investigate Association Between Diabetes Drug Onglyza and Heart Failure

    The US Food and Drug Administration (FDA) announced Tuesday that it is initiating an investigation into the safety of saxagliptin, a diabetes drug, and its association with heart failure. Background Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, and is marketed under the trade names Onglyza and Kombiglyze XR (saxagliptin and metformin) by Bristol-Myers Squibb (BMS), its manufacturer, and AstraZeneca. The drugs are FDA-approved as an adjunct to diet and exe...
  • DEA Classifies Bath Salt Chemical as Schedule I Drug After Oversight

    • 18 October 2012
    The Drug Enforcement Administration (DEA) has placed methylone, a powerful stimulant and psychoactive drug most notorious for its presence in bath salts, into its Schedule I of highly restricted drugs with no accepted medical use within the US. The drug is chemically similar to other drugs like Ecstasy (MDMA), which has been a Schedule I drug under the Controlled Substances Act (CSA) since 1985. DEA's actions would act to put into place a more permanent solution, o...
  • EMA Releases Draft Guideline on Acute Heart Failure Therapies

    The European Medicines Agency (EMA) has released a new draft guideline detailing what information it expects of sponsors developing new therapies to treat acute heart failure (AHF). The guideline , released 15 October, is intended to fill in gaps in its chronic heart failure guidance, explained EMA. AHF is composed of what EMA refers to as a "wide spectrum of symptoms and signs, accompanied by hemodynamic abnormalities and neuroendocrine activation that arise secondary...
  • UK NICE Gives Green Light to Servier's Procoralan for Chronic Heart Failure

    The UK's National Institute for Health and Clinical Excellence (NICE) on 7 August issued draft guidance recommending French drugmaker Servier Laboratories' cardiovascular drug Procoralan (ivabradine) be used by the National Health Service (NHS). In clinical trials, ivabradine has been shown to reduce mortality and improve quality of life in patients with certain forms of chronic heart failure. The draft guidance recommends ivabradine as an option for the treatment...