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    Challenges Providing Pharmaceutical Products to Syrian Refugees

    This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality. Introduction Providing healthcare aid to civilians during war and crisis is a complicated task. The Syrian war has impacted the healthcare system inside Syria and the neighboring countries. Large and small humanitarian organizations have wor...
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    UK Patients to Get Early Access to AbbVie's HCV Combo

    Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday. The combination, known as glecaprevir/pibrentasvir, is currently undergoing an expedited review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for its potential to treat patients across all six major genotypes of HCV, with or wi...
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    EMA to Continue to Allow Patient Involvement in CHMP Meetings

    The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before its Committee for Medicinal Products for Human Use (CHMP). In addition to continuing to invite patients to oral explanations on a case-by-case basis, EMA will also look to use additional methods and consult patients on a more regular basis. "This could include participating in CHMP discuss...
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    Pediatric Cancers: New Bill Seeks to Close Clinical Trial Requirement Loopholes

    A new bipartisan bill reintroduced in the House and Senate in late February, which could ultimately be attached to the reauthorized Prescription Drug User Fee Act (PDUFA), seeks to close the loopholes biopharmaceutical companies use to skirt around clinical trial requirements for cancer treatments in pediatric populations. Background Pediatric study requirements are included in both the Pediatric Research Equity Act (PREA), which requires biopharma companies to ...
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    Asia Regulatory Roundup: India Applies Price Controls on Stents (21 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Prevalence of Substandard Drugs in India’s Supply Chain Prompts Regulatory Proposals The Indian Ministry of Health has recommended increasing regulatory oversight of government facilities after a survey found 10% of drugs in the state supply chain are substandard. That figure is seven percentage points higher than at retail outlets, raising concerns the government is ...
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    CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics

    The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children. According to CTTI, a public-private partnership aimed at improving the quality and efficacy of clinical trials, challenges in enrolling and completing pediatric clinical trials for antibiotics leads to a situation where such drugs are used in children despite lacking adequate labeling for pediatric populations. Furthermore, ...
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    EU Parliament Committee Backs Report to Increase Access to Medicines

    The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Tuesday backed a draft report calling on the commission to analyze the impact of intellectual property on pharmaceutical access, as well as review the regulatory framework for orphan medicines, among other provisions. The draft , which a spokeswoman for the European Parliament told Focus that a final version will be made public by the end of this week, covers a menagerie of differ...
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    Italian Medicines Agency Cites Brazilian Drugmaker for GMP Violations

    The Italian Medicines Agency (AIFA) has banned the supply of certain drugs made by Antibioticos do Brasil (ABL) following an inspection of the company's San Paulo, Brazil facility in December. In total, AIFA cites the company for four critical and seven major deficiencies, including inadequate maintenance and cleaning; poor levels of training and awareness of good manufacturing practices (GMP); and insufficient environmental monitoring. As a result of the findings, AIFA...
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    Danish Regulator Suspends Parallel Importer's GMP Certificate

    The Danish Medicines Agency has suspended Danish parallel importer Europharma DK's manufacturing authorisation and good manufacturing practice (GMP) certificate over "serious breaches of compliance" uncovered during an inspection of the company's Esbjerg, Denmark site last month. According to Europharma DK's website, the company specializes in parallel import of drugs from other EU countries that it repackages and distributes in Denmark, Germany and Sweden. However, the...
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    FDA Officials Call for Including Adolescents in Adult Oncology Trials

    A team of officials at the US Food and Drug Administration (FDA) are calling for a "culture shift" by drugmakers, regulators and clinical investigators to encourage enrolling more adolescent patients in relevant "adult-type" cancer clinical trials. The officials made the call in a recent article in Clinical Cancer Research , where they argue that excluding older adolescents, ages 12 to 17, from adult oncology trials leads to delayed access to new treatments for those pa...
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    FDA Begins Consultation on Update to ICH Pediatric Clinical Trials Guidance

    The US Food and Drug Administration (FDA) on Monday launched a three-month public consultation on an addendum to the International Council for Harmonisation's (ICH) guidance on pediatric clinical trials. The addendum, E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population , is intended to supplement ICH's E11 guidance by expanding  the discussion on issues related to pediatric clinical trials in light of scientific and regulatory ...
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    EMA Offers New Guidance on Type II Variations and MA Extensions of Orphan Drugs

    The European Medicines Agency (EMA) has updated its post-authorization guidance on how extensions of marketing authorizations and type II variations may impact orphan-designated medicines. The updates follow the publication of a new  notice by the European Commission on the application of Articles 3, 5 and 7 of Regulation (EC) No. 141/2000 on orphan medicinal products . In this notice, the European Commission provides guidance on the application of the Orphan Regulation,...