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  • Regulatory NewsRegulatory News

    Nevada Fines Drugmakers $17M for Failing to Comply With Drug Pricing Law

    The Nevada Department of Health and Human Services this week sent letters to 21 diabetes drug manufacturers seeking $17.4 million in penalties for non-compliance with a new price transparency law. “This legislation requires the Department to compile a report of information related to prescription drugs used to treat diabetes. As part of the legislation, the Department of Health and Human Services (DHHS) can impose a penalty for companies who fail to provide the required...
  • Regulatory NewsRegulatory News

    FDA Reissues Two Draft Guidances on Blood Glucose Monitoring Test Systems

    The US Food and Drug Administration (FDA) on Thursday reissued two draft guidances to help manufacturers conduct performance studies on blood glucose monitoring test systems (BGMS) for point of care (POC) and over-the-counter (OTC) use and prepare 510(k) submissions for both device types. Both draft guidances propose changes to 2016 final guidances “based on feedback from stakeholders requesting more clarification on language,” FDA spokesperson Jennifer Rodriguez said...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Indian Court Rejects Abbott’s Plea to Stop Probe into Alleged Diabetes Cartel

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Posts Guidance on How to Manage and Communicate Drug Shortages   Australia’s Therapeutic Goods Administration (TGA) has posted guidance on the communication and management of drug shortages. The publication of the document comes five weeks before Australia makes the reporting of medicines shortages mandatory.   TGA proposed moving to a mandatory model in Apri...
  • Regulatory NewsRegulatory News

    Big Data and Pharmacovigilance: ICMRA Working Group Looks at Opportunities and Challenges

    The International Coalition of Medicines Regulatory Authorities’ (ICMRA) pharmacovigilance working group’s “big data” sub-group has released a policy paper examining the opportunities and challenges for big data and analytics, within the context of pharmacovigilance and to facilitate international collaboration when feasible. The sub-group, including experts from the European Medicines Agency, Health Canada and the UK’s Medicines and Healthcare products Regulatory Agenc...
  • Regulatory NewsRegulatory News

    EMA Adds Potential for Toe Amputation to SGLT2 Inhibitor Prescribing Info

    The European Medicines Agency (EMA) on Friday noted the potential increased risk of lower limb amputation (mostly affecting the toes) in patients taking the SGLT2 inhibitors canagliflozin, dapagliflozin and empagliflozin for type 2 diabetes. “Patients taking these medicines are reminded to check their feet regularly and follow their doctor’s advice on routine preventative foot care. They should also tell their doctor if they notice any wounds or discoloration, or i...
  • Regulatory NewsRegulatory News

    FDA Tells Sanofi and Celgene to Stop Airing Misleading TV Advertisements

    The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday called on Sanofi-aventis and Celgene to stop broadcasting two of their direct-to-consumer television advertisements due to their misleading nature. The similar letters, which were the sixth and seventh untitled and warning letters issued by OPDP in 2016, both say: ““The presentation of these compelling and attention-grabbing visuals, all of which are unrelated to the risk mes...
  • Feature ArticlesFeature Articles

    Insulin: The First Truly Miracle Drug

    This article will discuss diabetes, the process of the discovery of insulin and provide brief biographies of two intrepid people involved. Introduction Although a number of so called blockbuster drugs claim to be miracles, none has yet reached the status of injectable insulin. It was the first drug to treat diabetes mellitus that could virtually raise the dead, enabling dying children to laugh and play again and to lead a somewhat normal life. 1 Insulin transforms a ...
  • Regulatory NewsRegulatory News

    HHS Looks at New Ways to Track Adverse Events Linked to Anticoagulants, Diabetes Drugs and Opioids

    The US Department of Health and Human Services (HHS) on Wednesday proposed six new inpatient and outpatient measures to track as part of efforts to reduce adverse drug events (ADEs) from anticoagulants, diabetes agents and opioid analgesics. Based on input from the Federal Interagency Workgroups for Adverse Drug Events, the six national measures and targets for the reduction of ADEs are being proposed in line with the ADE Action Plan from 2014. The primary ADE...
  • Regulatory NewsRegulatory News

    UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges. “Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA to Revise Trial Guidance on Hemophilia, Crohn’s, Ulcerative Colitis, Diabetes and Bipolar Disorder (4 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Boom in Hemophilia R&D Prompts EMA to act to Prevent Enrollment Bottleneck The European Medicines Agency (EMA) is planning to revise its guideline on development of drugs to treat hemophilia to cut the risk of patient enrollment bottlenecks slowing progress. EMA began the process after becoming concerned that the minimum data requirements of its current guideline are i...
  • Regulatory NewsRegulatory News

    New Studies Push FDA to Expand Label for Popular Diabetes Drugs

    Following a review of the medical literature, the US Food and Drug Administration (FDA) on Friday expanded the labels of 18 metformin-containing medicines for diabetes, noting that they can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. Prior to the label change, metformin, which at least one researcher has said is "little removed from a herbal remedy of the middle ages," was stro...
  • Regulatory NewsRegulatory News

    FDA: Some Type 2 Diabetes Drugs May Increase Risk of Heart Failure

    The US Food and Drug Administration (FDA) on Tuesday updated its safety communication for Type 2 diabetes medicines containing saxagliptin and alogliptin as they may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. FDA has added new warnings to the following drug labels about this safety issue: AstraZeneca’s Onglyza (saxagliptin) AstraZeneca’s Kombiglyze XR (saxagliptin and metformin extended release) Takeda’...