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    RAPS' Regipedia, a Wiki Built for Regulatory Pros

    One of RAPS’ newest member-exclusive resources may actually be somewhat familiar to you already. RAPS Regipedia is an online compilation of regulatory terms and definitions originally derived from RAPS’ Acronyms & Definitions guides. For nearly two decades, regulatory professionals have been using Acronyms & Definitions guides to look up all manner of terms related to the regulation of drugs, medical devices, biologics and other healthcare products. RAPS published...
  • Regulatory NewsRegulatory News

    EMA, HMA Set 10 Priorities for Big Data

    A report from the European Medicines Agency (EMA) and Heads of Medicines Agencies’ (HMA) joint Big Data Task Force released Monday sets out recommendations to unlock the potential of data in medicines regulation.   “Coupled to rapidly developing technology, big data can complement the evidence from clinical trials and fill knowledge gaps on a medicine, and help to better characterize diseases, treatments and the performance of medicines in individual healthcare systems...
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    House Committee Quizzes FDA on Complex Generic Drugs

    A bipartisan group of House Energy & Commerce Committee leaders last Friday sent a letter to US Food and Drug Administration (FDA) Commissioner Stephen Hahn seeking information on the agency’s efforts to approve complex generic drugs more quickly. The congressmen said they are trying to understand if FDA needs additional authority to improve the approval process for complex generic drugs, which can be more difficult to formulate or manufacture than other generic drugs. ...
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    EU NCAs to Offer Simultaneous Scientific Advice for Drug Developers

    As part of efforts to better align scientific advice across the EU, beginning 1 February, a dozen national competent authorities (NCAs) will participate in a pilot project to allow drug developers to obtain two NCA opinions simultaneously. The multi-national discussions aim to provide two NCA opinions within one application, in addition to earlier opinions, better explanations for possibly conflicting opinions, increased interactions between NCAs and the potential for f...
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    OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show

    As the spotlight on foreign drug and medical device facilities brightens because of impurity concerns and a lack of US Food and Drug Administration (FDA) staff abroad, the total number of Official Action Indicated (OAI) classifications continued to fall in 2019, and US-based facilities still saw the lion’s share. A look into FDA’s inspection classification database for the drug, device and biologic centers reveals how China and India’s share of the overall OAI classif...
  • ReconRecon

    Recon: China Says New Coronavirus Can Spread From Human to Human; GSK, 23andMe Seek First Drug Target

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Despite US law, many clinical trial results go unreported ( Reuters ) ( The Lancet ) FDA delays decision on Intercept's NASH drug by three months ( PMLive ) ( BioPharmaDive ) Patients Still Struggle To Balance High Costs Of MS Treatment, Despite Generic ( NPR ) Judge slashes $8B Risperdal award against J&J to $6.8M ( Reuters ) ( NYTimes ) Medicare’s Part D Do...
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    FDA to Allow Online Submissions of Orphan Designation Requests

    As part of work building on the US Food and Drug Administration’s (FDA) orphan drug modernization plan from 2017 , the agency said Friday that later this year it will move from a paper-based process to a new cloud-based online submission portal for orphan drug designation requests. The shift to online submissions will ease the process of making orphan drug designation requests, which are currently  mailed into the Office of Orphan Products Development (OOPD) on a CD. ...
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    EMA Suspends Picato Authorization, Confirms Limits for High-Strength Estradiol Creams

    The European Medicines Agency (EMA) is following a recommendation from its Pharmacovigilance Risk Assessment Committee (PRAC) this week to suspend the marketing authorization for Leo Pharma’s actinic keratosis cream Picato (ingenol mebutate), while the agency investigates reports of increased rates of skin cancer associated with the drug.   The suspension follows PRAC’s investigation of Picato’s safety last year after multiple studies showed a higher rate of skin can...
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    MAPP Further Explains FDA Process for Reviewing REMS Assessment Reports

    The US Food and Drug Administration (FDA) last month offered a new Manual of Policies and Procedures (MAPP) to explain how the Center for Drug Evaluation and Research (CDER) reviews risk evaluation and mitigation strategy (REMS) assessment reports submitted to the agency. Although the statute does not specifically describe how companies should conduct their assessments, the agency has released two draft guidances (one on survey methodologies and another on planning and ...
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    'CurAll' or 'Bestmab': FDA to Study How Proprietary Names Affect Perceptions

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is planning a study to investigate how proprietary drug names affect consumers’ and/or healthcare providers’ perceptions and whether they might overstate the efficacy of a drug. During FDA’s prescription drug approval process, sponsors propose proprietary names for their products, which are reviewed by the Office of Drug Safety, the relevant medical office and OPDP. OPDP reviews nam...
  • ReconRecon

    Recon: FDA Panel Split on Durect Non-Opioid Painkiller; Novo’s Ozempic Gains CV Indication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel split over approval of Durect's non-opioid painkiller ( Reuters ) ( Endpoints ) Republican FTC commissioner says she supports Medicare negotiating drug prices ( The Hill ) ( STAT ) Novo Nordisk's diabetes pill Rybelsus to be covered by Express Scripts ( Reuters ) Novo Nordisk's blockbuster Ozempic wins FDA label boost with CV indication ( Endpoints )...
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    FDA Warns of Potential Contamination With Some Cardinal Health Surgical Gowns

    The US Food and Drug Administration (FDA) on Thursday advised health care providers to stop using certain Cardinal Health Level 3 surgical gowns and PreSource procedural packs due to possible product contamination.   “Cardinal Health recommends, and the FDA agrees, that customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the product...