• Regulatory NewsRegulatory News

    OIG Report on FDA’s Postmarket Surveillance of Devices Coming in 2020

    The US Department of Health and Human Services’ Office of Inspector General (OIG) will issue a report next year on the US Food and Drug Administration’s (FDA) postmarket surveillance of medical devices, which has come under fire in recent months. OIG says it will assess and describe how FDA's “established passive postmarket surveillance system” identifies and tracks safety concerns and responds to them. “We will also describe how elements of FDA's newer surveillance ...
  • Regulatory NewsRegulatory News

    Industry Calls on FDA to Expand on Inactive Ingredient Database Guidance

    Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to expand and clarify its recent draft guidance on how to use its inactive ingredient database (IID).   The 13-page draft guidance , released for comment in July, provides recommendations for drugmakers on using FDA’s IID, an online repository of information about excipients used in FDA-approved products, during drug development.   According to FDA, drugmakers can reference ina...
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    Belgium Inspects Companies Delaying or Preventing Biosimilar Competition

    The Belgian Competition Authority (BCA) said recently that it’s inspecting the premises of companies suspected of using restrictive practices to limit, delay or prevent the entry of biosimilar competition. While the authority did not offer any details into what companies are being inspected, the authority did say that this is a preliminary step into its investigation of such restrictive practices. “Conducting inspections does not prejudge the outcome of the investiga...
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    EC Unveils Designating Authority’s Final Assessment Form Under MDR, IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Thursday released a final assessment form for authorities designating conformity assessment bodies (CABs) and notified bodies (NBs) under the EU Medical Devices Regulation (MDR), which takes effect next May, and the In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022. The form includes space to describe the assessment carried out by the designating authority and whether all correctiv...
  • ReconRecon

    Recon: FDA Panel Backs Shionogi Antibiotic for Complicated UTIs; J&J to Settle Surgical Mesh Probe for $117M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca breast cancer treatment gets FDA priority review ( Reuters ) ( Endpoints ) ( Press ) Johnson & Johnson agrees to pay about $117 million to settle US states' mesh probe ( Reuters ) Drug Giants Close In on a $50 Billion Settlement of Opioid Cases  ( NYTimes ) ( Reuters ) Judge summons drug company CEOs to court to discuss opioid settlement: source ( ...
  • Regulatory NewsRegulatory News

    UK Alerts to Teva Recall of Heartburn Medicines Over Impurity Fears

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday alerted to a recall of its heartburn medicine ranitidine following similar recalls due to possible contamination with an impurity called NDMA (N-nitrosodimethylamine), which may increase the risk of cancer. For health professionals, the MHRA says to stop supplying the products immediately and quarantine all remaining stock and return it to suppliers. Andrew Gray, MHRA deputy director of...
  • RoundupsRoundups

    EU Regulatory Roundup: UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup   The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit.   ...
  • RAPS' LatestRAPS' Latest
    RAPS AnnouncementsRAPS Announcements

    RAPS Welcomes Colorado Chapter

    RAPS has announced the official launch of the RAPS Colorado Chapter . The group first began as a RAPS-affiliated local networking group before becoming a full chapter. Chapter leaders and other representatives attended RAPS’ recent Regulatory Convergence in Philadelphia, where they were welcomed and acknowledged by RAPS Executive Director Paul Brooks. “We are so pleased to officially welcome the RAPS Colorado Chapter,” said Brooks. “RAPS chapters are a vital part of ou...
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    FDA Finalizes Guidance on PDUFA Fee Waivers, Reductions and Refunds

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance providing advice to drug and biologic sponsors looking to apply for Prescription Drug User Fee Act (PDUFA) fee waivers, reductions and refunds.   Specifically, the guidance explains the various types of fee waivers, reductions and refunds offered to industry, such as those for pressing public health needs, small business entities and when paying the fee would be a significant barrier to an appl...
  • Regulatory NewsRegulatory News

    Another Record Year for Generic Drug Approvals but Questions on Competition Remain

    For each of the last five years, the US Food and Drug Administration (FDA) has set generic drug approval records, but questions have lingered on whether these high approval numbers are translating into competition. FY 2019 figures show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals), which breaks FDA’s previous all-time record of 971 full and tentative approvals for FY 2018 . And although the abbreviated new drug application (...
  • Feature ArticlesFeature Articles

    Practical Solutions to Pharmaceutical Labeling Challenges

    Introduction   Have you ever wondered what the label management process entails? Or have you ever felt overwhelmed by the task of creating, editing and maintaining a product label while preparing for a new product launch or during product lifecycle management?   A health authority-approved pharmaceutical product label contains key information and data intended to educate healthcare providers and/or patients about how to safely use and prescribe a medication. As a...
  • ReconRecon

    Recon: Alexion to Acquire Achillion for $930M; Lilly’s Pancreatic Cancer Drug Fails in Phase III Trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Alexion acquiring Achillion to expand reach into rare, immune-related disease ( STAT ) ( Xconomy ) ( Endpoints ) ( Press ) Drug Distributors in Talks to Settle Opioid Litigation for $18 Billion ( WSJ ) ( Reuters ) J&J Makes $4 Billion Opioid Offer as Distributors Seek Deal ( Bloomberg ) Teva Proposes $15 Billion Deal To Settle Opioid Claims ( Jerusalem Post ) ...