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    FDA to Develop Importation Policy for Sole-Source Drugs

    At the direction of Department Health and Human Services (HHS) Secretary Alex Azar, the US Food and Drug Administration (FDA) on Thursday announced it will work to develop a policy to facilitate the importation of certain sole-source drugs in response to dramatic price hikes and supply disruptions. The policy is an attempt to head off the tactic employed by Martin Shkreli and Turing Pharmaceuticals in 2015 when it acquired the off-patent drug Daraprim (pyrimethamine), t...
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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 19 July 2018 to include: Novartis plans to use one of its two PRVs. SIGA Techn...
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    Real World Evidence: FDA Finalizes Guidance on Using EHRs in Clinical Studies

    To advance the use of real world evidence in regulatory decision making, the US Food and Drug Administration (FDA) on Wednesday finalized its guidance detailing a policy for using electronic health record (EHR) data in FDA-regulated clinical investigations.  According to FDA, conclusions drawn from data sourced from EHRs could be used to support the approval of new indications for already-approved drugs or to satisfy post-approval study requirements.  "Every clinical us...
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    EU, Japan Expand Mutual Recognition Agreement

    The European Medicines Agency (EMA) announced on Wednesday that the EU and Japan have expanded their 14-year-old mutual recognition agreement for the first time since its inception to include new types of products and active pharmaceutical ingredients (APIs).  Since 2004, the EU and Japan have mutually recognized good manufacturing practice inspections conducted by each other's medicines regulators, EMA and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).  Now...
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    FDA Lays Out New Pathways for Nonprescription Drugs

    In a draft guidance released Tuesday, the US Food and Drug Administration (FDA) details two proposed approaches to making more drugs available without a prescription. Under current regulations, nonprescription drugs can come to market either by conforming to an over-the-counter (OTC) monograph or via FDA's new drug application (NDA) process. To qualify for sale without a prescription, FDA must determine that a drug is safe and effective "under the conditions prescrib...
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    OTC Monograph Reform Ticks Forward With Passage of House Bill

    The US House of Representatives on Monday voted to pass a bill to reform the over-the-counter (OTC) monograph process by creating a user fee program to speed FDA's reviews of OTC monographs. The bipartisan bill, known as the Over-the-Counter Monograph Safety, Innovation and Reform Act of 2018 (H.R. 5333), cleared the House by voice vote. Under the bill, FDA would collect fees from companies that own facilities identified as OTC monograph drug facilities. Contract m...
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    Hypertension Drug Development: FDA Draft Guidance Outlines Recommendations

    The US Food and Drug Administration (FDA) on Friday issued draft guidance providing recommendations for sponsors looking to develop drugs to treat hypertension in patients already taking several other antihypertensive medications.  FDA says the guidance was developed in response to requests from drugmakers who sought input from the agency on treating resistant hypertension, or hypertension that is "not adequately controlled by maximally tolerated doses of three or more a...
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    EU Pharmacovigilance Fees Rise 1.7 Percent

    The European Commission on Wednesday raised the fees pharmaceutical companies pay related to pharmacovigilance activities in the EU by 1.7% to keep pace with inflation in 2017. Pharmacovigilance fees in the EU are set by Regulation (EU) No 658/2014 , which includes provisions for the European Commission to adjust the fees to keep up with the rate of inflation as measured by the European Index of Consumer prices. The fees were last increased in February by 1.4% aft...
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    EMA's PRAC Elects its Second Chair

    The European Medicines Agency (EMA) on Wednesday announced that Sabine Straus of the Netherland's Medicines Evaluation Board (MEB) has been elected to chair the agency's Pharmacovigilance Risk Assessment Committee (PRAC) for a three-year term.  Straus will be replacing June Raine, who heads the UK's Medicines and Healthcare products Regulatory Agency's vigilance and risk management program, as the committee's second chair beginning September 2018.  Raine, who was  elect...
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    Arog Lands OPDP Untitled Letter Over Promotional Statements for Investigational Drug

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter—its third in 2018—to Arog Pharmaceuticals over promotional claims for its investigational drug crenolanib besylate, which is being developed to treat FLT3-mutated acute myeloid leukemia (AML).  In recent years, OPDP has seen a major drop in enforcement letters, culminating in a record low of just five warning and untitled letters sent to  Orexigen Therap...
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    EMA Finds Gaps in Drugmakers' Brexit Preparedness

    After surveying industry on its preparedness for Brexit, the European Medicines Agency (EMA) says it has "serious concerns" over some drugmakers' ability to take the actions necessary to smoothly transition once the UK exists the EU in March 2019.   Based on the survey results, EMA says that 58% of drugmakers with a centrally authorized human or veterinary medicine with at least one important part of their regulatory process in the United Kingdom "are on track with t...
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    FDA Revises Decade-Old Guidance on Smallpox Antivirals

    In an effort to support the development of antiviral drugs to treat or prevent smallpox (variola virus) infection, the US Food and Drug Administration (FDA) on Tuesday updated its decade-old drug development guidance.   Background   After extensive vaccination efforts, the World Health Organization formally declared smallpox to be eradicated in the wild in 1980. Prior to that, outbreaks of the virus, especially the more severe variola major , caused millions of de...