• Regulatory NewsRegulatory News

    EMA Extends Valsartan Review to Include Four More Active Substances

    The European Medicines Agency (EMA) announced Friday it has extended its review of two impurities classified as probable human carcinogens from its initial valsartan focus to include medicines containing four other “sartans.”   The move to include candesartan, irbesartan, losartan and olmesartan in the ongoing review was prompted by the detection of “very low levels of N-nitrosodiethylamine (NDEA)” in the losartan products manufactured by Hetero Labs in India, EMA sai...
  • Grammar, Logic and Rhetoric: the Trivium

    This article discusses the intellectual benefits of a “liberal arts” education focused on its three foundational elements: grammar, logic and rhetoric and reviews ways in which the skills learned by studying “the Trivium” could benefit regulatory professionals in carrying out their tasks. Introduction The term “liberal arts” denotes the seven branches of knowledge that provide an introduction to a lifetime of learning. The concept is classical, but the term liberal arts...
  • Regulatory NewsRegulatory News

    DITTA Calls on FDA, Health Canada to Take Up Proposed IMDRF Work on Cybersecurity

    A new work item on cybersecurity was proposed at the International Medical Device Regulators Forum (IMDRF) management committee hearing this week in Beijing, China by the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA).   Pending the outcome meeting statement to be released by IMDRF chair China Food and Drug Administration, DITTA chair Patrick Hope told Focus that the proposed new work item is centered on three areas of cybersec...
  • Regulatory NewsRegulatory News

    CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended thirteen new medicines for EU approval and reaffirmed its negative opinion of Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys (eteplirsen).   Among the thirteen drugs recommended for approval are three orphan drugs, three Neulasta (pegfilgrastim) biosimilars, two anti-cancer drugs and a new antibiotic.   The three orphan medicines include...
  • Regulatory NewsRegulatory News

    FTC Charges First Marketer of Intravenous Products

    The Federal Trade Commission (FTC) has, for the first time, charged a marketer and seller of intravenously injected therapy products, known as iV Cocktails, with making a range of “deceptive and unsupported health claims” about their ability to treat serious diseases. The proposed FTC order prevents the company, which operates clinics in Texas and Colorado, and its owner from making such claims unless they can be supported by competent and reliable scientific evidence. ...
  • Regulatory NewsRegulatory News

    FDA Releases ADMA Biologics Form 483 as Company Announces VAI Status

    The US Food and Drug Administration (FDA) this week unveiled a Form 483 from April for ADMA Biologics, a company that previously received a complete response letter related to manufacturing deficiencies. Earlier this month and prior to the 483’s release, however, ADMA said FDA’s inspection database classification website has been updated and “confirms ADMA’s compliance status has improved to Voluntary Action Indicated (VAI).” FDA explains the VAI designation as: “O...
  • ReconRecon

    Recon: Medtronic to Acquire Mazor Robotics for $1.6B; Dozens Lose Sight After Being Injected with Compounded Eye Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Medtronic to Acquire Mazor Robotics ( Press ) ( MassDevice ) We Can’t Afford the Drugs That Could Cure Cancer ( WSJ ) At Least 68 People Are Nearly Blind After A Botched Drug Was Injected Into Their Eyeballs ( BuzzFeed ) Why Former Novartis CEO Joe Jimenez Joined A Microbiome Startup's Board ( Forbes ) ( Endpoints ) Sloan Kettering’s Cozy Deal With Start-Up I...
  • Regulatory NewsRegulatory News

    Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance

    Drugmakers GlaxoSmithKline (GSK), Sanofi and Perrigo are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft guidance on field alert report (FAR) submissions. The draft guidance, released for comment in July , describes FDA’s current thinking on submitting FARs for new drug applications (NDAs) and abbreviated new drug applications (ANDAs). In the guidance, FDA calls on applicants to submit a FAR within three working days ...
  • Regulatory NewsRegulatory News

    Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

    Just days since FDA, EMA and Health Canada announced that a second impurity, called N-nitrosodiethylamine (NDEA), has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals and FDA has released a third Form 483 for the company. Following inspections in July and August, FDA issued the 483 with 11 observations, with specific issues raised about the firm’s quality unit. “The system for managing quality to ensure confidence that the API [active pharmac...
  • Regulatory NewsRegulatory News

    FDA Previews Patient-focused Report on Opioid Use Disorder

    The US Food and Drug Administration (FDA) offered a sneak peek Thursday into a new report on the impact of opioid use disorder (OUD) from the perspectives of about 155 patients.   The report is set to be released later this year, said FDA operations research analyst Sara Eggers during a joint public workshop between the agency and the Duke Margolis Center for Health Policy at the National Press Club in Washington.   Preliminary results highlighted by Eggers offer i...
  • Regulatory NewsRegulatory News

    Monetary Penalties for Failing to Report Trials: FDA Drafts Guidance

    Failing to submit trial data to ClinicalTrials.gov may start to cost drug and device makers, the US Food and Drug Administration (FDA) said Thursday in draft guidance. According to FDA, the 8-page draft is meant to address four issues: How FDA’s centers identify whether responsible parties have failed to submit required clinical trial registration and/or results information to ClinicalTrials.gov or submitted false or misleading information to the data bank, and wheth...
  • ReconRecon

    Recon: Amicus Buys Celenex Gene Therapy Portfolio for $100M; EU Approves 5th Humira Biosimilar

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amicus Therapeutics acquires portfolio of gene therapies targeting neurologic disorders ( STAT ) ( Endpoints ) ( Forbes ) ( Xconomy ) In the battle for life sciences companies, one state shows up behind enemy lines ( STAT ) Life sciences industry rallies behind Calif. bill to prevent a nightmare scenario for clinical research ( STAT ) Shares in Molecular Templ...