• ReconRecon

    Recon: FDA Panel Backs GSK's OTC Nicotine Spray; Swiss Competition Watchdog Raids Makers of Stomach Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Industry groups push back against ‘troubling’ FDA crackdown on genetic tests used to predict response to drugs ( STAT ) GSK's over-the-counter nicotine oral spray gets FDA panel backing ( Reuters ) Ginkgo Bioworks scores an eye-popping valuation with latest fundraise ( STAT ) Insys Bankruptcy Plan Comes Up Short in Paying Justice Department ( WSJ ) Bristol jo...
  • Regulatory NewsRegulatory News

    Citizen Petitions Delaying Approvals: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance discussing some of the considerations that the agency will take into account when determining whether citizen petitions and petitions for a stay of agency action are submitted with the primary purpose of delaying the approval of a pending generic drug, biosimilar or 505(b)(2) application. The final guidance comes as FDA in February explained its concerns to Congress that such petitions are often...
  • Regulatory NewsRegulatory News

    FDA Lays Out Tech Modernization Action Plan

    As part of efforts to prepare for the continued rise in data-rich applications and to help fill the gap separating scientific advances and new therapies, the US Food and Drug Administration (FDA) on Wednesday unveiled its Technology Modernization Action Plan (TMAP). Near-term modernization in computer hardware and software technologies are the focus of FDA’s TMAP, which offers a broad overview of how the agency needs to adapt. For instance, the TMAP report notes that FD...
  • Regulatory NewsRegulatory News

    Not Quite a Breakthrough Device, FDA Introduces New Safer Technologies Program

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance to introduce a new, voluntary program for certain medical devices and device-led combination products that are expected to improve the safety of currently available treatments or diagnostics but are used for morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices that may be included in this Safer Technologies Program” or “STeP” may include t...
  • Feature ArticlesFeature Articles

    Breaking Down UDI Questions

    This article answers questions and clears up ambiguities related to the Unique Device Identification (UDI) system developed for medical devices related to US and European Union (EU) regulations. The author presents an in-depth discussion of terms including base package, unit of use, packaging levels, UDI databases, accessories and spare parts, UDI ownership and scanning versus verifying. She also looks at UDI development outside of the US and EU.   Introduction   ...
  • Regulatory NewsRegulatory News

    MHRA Updates No-Deal Brexit Device Guidance

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday updated its no-deal Brexit guidance for medical devices, adding a new section on the role of the “UK Responsible Person.” According to the guidance, the UK Responsible Person, who must be established in the UK, acts on behalf of a non-UK manufacturer to carry out tasks for the manufacturer, which include registering with the  MHRA  before a device is placed on the UK market. “Only a manu...
  • ReconRecon

    Recon: Senators Urge More FTC Scrutiny for Pharma Mega-Mergers; WHO Panel Warns on Pandemic Risk

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Grassley's fight to win over GOP on drug prices ( Politico ) Hearing on "Profits Over Consumers: Exposing How Pharmaceutical Companies Game The System" ( House E&C ) Medicare Part D rebates ‘substantially’ reduced drug spending, but not enough to offset price hikes ( STAT ) US Senators urge FTC to scrutinize multi-billion dollar pharma mergers ( Reuters ) ( ST...
  • Regulatory NewsRegulatory News

    OGD Explains How it Reviews and Conducts Pre-ANDA Meetings

    In a newly issued manual of policies and procedures (MAPP), the US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) explains how it evaluates and conducts two types of meetings under its pre-abbreviated new drug application (ANDA) program.   In the eight-page MAPP, the office explains its criteria for granting or denying product development and pre-submission pre-ANDA meetings. The MAPP also provides timeframes for how the agency conducts those meetin...
  • Regulatory NewsRegulatory News

    Population Pharmacokinetics: Drugmakers Seek Clarity and Additions to Revised FDA Guidance

    About a dozen drugmakers and industry groups recently offered their opinions on a revised US Food and Drug Administration (FDA) draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. The comments largely seek specific tweaks to the 23-page revised draft, which was released in July , although some of the comments also seek further clarity and new additions to the guidance. Indu...
  • Feature ArticlesFeature Articles

    Challenges in Clinical Evaluation for the EU Versus China

    This article illustrates how to write a Clinical Evaluation Report (CER) based on China’s National Medical Products Administration (NMPA) guidance and how to convert and submit existing EU CER requirements for NMPA, formerly the China Food and Drug Administration (CFDA). The authors compare and contrast the process of converting an MDR compliant CER for submission in China by demonstrating the differences in requirements, outlining specific requirements for China and p...
  • Regulatory NewsRegulatory News

    FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

    The US Food and Drug Administration (FDA) on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada. The collaboration, dubbed Project Orbis , was launched with FDA’s decision with TGA and Health Canada to grant accelerated approval to Eisai's Lenvima (lenvatinib) in combination with Merck's Keytruda (pembrolizumab) for the tre...
  • Regulatory NewsRegulatory News

    CDRH Warns Idaho Wheelchair Manufacturer for Unapproved Modifications

    The videos at 21 st Century Scientific’s website wheelchairs.com show people taking their wheelchairs off-road, in the sand and at high speeds. But the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told the Idaho-based company in a warning letter posted Tuesday that these modifications to their wheelchairs were never approved by the agency. “Use on these terrains and functions that enable the device to lift the user, tilt the...