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    FDA Warns BD for GMP Violations at Lock Flush Syringe Facility

    The US Food and Drug Administration (FDA) has warned medical device maker Becton Dickinson (BD) for good manufacturing practice (GMP) violations at the company’s Franklin, Wisconsin facility.   The warning letter comes after two-and-a-half-month inspection this summer during which FDA found the company’s pre-filled heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringe products to be adulterated.   The warning is BD’s second in 2018 after...
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    FDA Warns Datascope Over QSR, Reporting Violations

    The US Food and Drug Administration (FDA) sent a warning letter to New Jersey-based medical device maker Datascope Corporation over quality system regulation (QSR) and medical device reporting (MDR) violations.   Datascope, which was bought by the German multinational Maquet in 2008, markets a variety of cardiovascular devices such intra-aortic balloon catheters and cardiopulmonary bypass tubing packs.   The warning letter comes after an inspection of the company's...
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    FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices

    The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years. A Federal Register notice on guidance released Friday, which FDA said takes effect immediately, said: "FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Ag...
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    FDA Plots New Enforcement Approach for Homeopathic Products

    The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic. The agency says it will begin prioritizing enforcement actions against such homeopathic products with reported safety concerns, intended for preventing or treating serious or life-threatening diseases and products aimed at vulnerable populations, among others. However, without new Co...
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    FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts

    The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C. Becky Wood, chief counsel for FDA, keynoted the conference and discussed the opioid crisis, and in particul...
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    FOIA'd Documents Show FDA's Rationale Against Marijuana Rescheduling

    In a report and other documents obtained by Vice News via the Freedom of Information Act (FOIA) , the US Food and Drug Administration (FDA) lays out its case against rescheduling marijuana. FDA's recommendation on the matter was cited by the Drug Enforcement Administration (DEA) when it denied two petitions to reschedule marijuana last August . Despite efforts by medical marijuana advocates and a growing number of states (25, plus the District of Columbia) where med...
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    Asia Regulatory Roundup: CFDA Continues Crackdown on Dishonest Drug Manufacturers (27 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CRO Complaints About Online Portal Prompt CDSCO to Convene Meeting The Deputy Drugs Controller of India (DDCI) has convened a meeting to discuss sponsor and contract research organization (CRO) complaints about the Sugam online portal. Sponsors and CROs made the complaints after encountering problems when trying to use Sugam to apply for regulatory clearances regar...
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    Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling

    Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine . For years the US has been in the grips of a prescription drug abuse epidemic, in part driven by the availability of hydrocodone and other opioids such as oxycodone, codeine and methadone. In 2013, more than 200 million prescriptions for opioids we...
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    DEA to Increase Marijuana Production Quota to Meet Demand of Medical Researchers

    The US Drug Enforcement Administration (DEA) is proposing to more than triple the amount of marijuana it will allow to be produced this year in the hopes of meeting the demand of researchers studying new medicinal uses for the drug, it has announced. Background In the US, the manufacture and production of marijuana is controlled by the DEA, whose authority to do so stems from the Controlled Substances Act (CSA) —a law which categorizes drugs in accordance with their ri...
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    House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved'

    The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products. Background The bill in question, the  Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
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    DEA Scheduling Reform Bill Moves Forward in House

    The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly. Background The bill in question, the Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
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    DEA Scheduling Process Targeted by Legislators Hoping to Speed up Drug Approvals

    The House of Representatives is in the advanced stages of considering legislation that could make it easier for some drug products to reach the market after being approved by the US Food and Drug Administration (FDA). Background In a notice posted to the House Energy and Commerce (E&C) Committee's website on 20 January 2015, Rep. Joe Pitts (R-PA) said he will hold a meeting on 27 January 2015 to consider several pieces of legislation, including the Improving Regulat...