• 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 ) ...
  • Regulatory NewsRegulatory News

    EC Publishes New Guidelines on Good Clinical Practices for ATMPs

    Thanks to a 2007 regulation on advanced therapy medicinal products (ATMPs), the European Commission (EC) on Wednesday released new guidelines on the good clinical practice (GCP) requirements for these complex and innovative products that can include gene and cell therapies. The 15-page guidelines discuss clinical trial design, non-clinical studies, quality of the investigational ATMPs, the safe conduct of the clinical trial, upstream interventions on subjects and admini...
  • Regulatory NewsRegulatory News

    VA Works With UL to Ensure Cyber Safety of Connected Devices

    The US Department of Veteran Affairs (VA) recently completed a two-year Cooperative Research and Development Agreement (CRADA) for medical device cybersecurity with UL, a science safety organization that has cybersecurity standards and conformity assessment programs.   Between 2016 and 2018, the VA used the UL 2900 Series of Standards as a benchmark to identify critical cybersecurity vulnerabilities in connected medical device deployment and lifecycle management, as we...
  • Regulatory NewsRegulatory News

    RWE to Supplement RCTs: FDA Projects Continue

    The US Food and Drug Administration (FDA) has been working with several different data and research companies to further its understanding of how real-world data (RWD) and real-world evidence (RWE) can help to inform its regulatory decision making. One such company that has signed an RWE research collaboration with FDA is COTA, Inc., which is working on a project related to replicating a breast cancer study. Andrew Norden, chief medical officer of COTA, told Focus ...
  • Regulatory NewsRegulatory News

    FDA Addresses Questions on 510(k) Third-Party Review Program

    The US Food and Drug Administration (FDA) recently responded to several comments related to a 2018 draft guidance on its 510(k) third-party review program, which was crafted because of the latest reauthorization of the Medical Device User Fee Act . The third-party review program is intended to allow for the review of devices by certain outside organizations to provide manufacturers of lower risk devices with an alternative review process that allows FDA to best utilize...
  • Regulatory NewsRegulatory News

    FDA Warns Indian, Bahamian Drugmakers

    The US Food and Drug Administration (FDA) earlier this month sent warning letters to Indian drugmakers Glenmark Pharmaceuticals and Torrent Pharmaceuticals and Bahamian drugmaker Coral Pharmaceuticals over good manufacturing practice (GMP) violations at their facilities.   Glenmark   In its warning letter to Glenmark Pharmaceuticals, FDA cites the company for failing to adequately investigate multiple complaints, out-of-specification (OOS) test results and temperat...
  • ReconRecon

    Recon: Merck KGaA Looks to Machine Learning to Prevent Drug Shortages; J&J Raises Outlook Despite Mounting Legal Challenges

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US J&J boosts outlook despite uncertainty over legal costs  ( Financial Times ) ( WSJ ) ( CNBC ) ‘Gene therapy headwinds’ are blamed for biotech stock woes ( STAT ) House progressives plot overhaul of Pelosi drug pricing bill ( STAT ) Eli Lilly to shutter neuroscience R&D center next year  ( Fierce ) ( Endpoints ) Faced With a Drug Shortfall, Doctors Scramble to...
  • Regulatory NewsRegulatory News

    EC Offers New Site Suitability Template Under Incoming Clinical Trial Regulation

    The European Commission (EC) on Tuesday published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which has yet to take effect. The template was developed and endorsed by the EU Clinical Trials Expert Group on 9 October to comply with the new regulation, known as Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use. “However, this templat...
  • RoundupsRoundups

    Asia Regulatory Roundup: Pakistan Seeks Expert to Help Harmonize Regulations With Global Best Practices

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   New Zealand Extends Timelines for Reporting Medical Device Adverse Events   The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has given companies more time to report adverse events involving their medical devices.   Under the old rules, manufacturers of medical devices had seven calendar days to report incidents of actual or potential death...
  • Regulatory NewsRegulatory News

    Patient Experience Data: Researchers Call for More Consistency From FDA

    Researchers at drugmaker Sanofi are calling on the US Food and Drug Administration (FDA) to make its publication of patient experience data (PED) in review documentation more consistent after reviewing applications approved in the first full year after a requirement of the 21 st Century Cures Act compelled the agency to do so.   Under Section 3001 of the 21 st Century Cures Act , FDA is required to "publish a brief statement on any patient experience data or relat...