• 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 ...
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    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    The US Food and Drug Administration (FDA) recently responded to several comments related to a 2018 draft guidance on its 510(k) third-party review program, which was crafted because of the latest reauthorization of the Medical Device User Fee Act .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...
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    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...
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    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...
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    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...
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    PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use. PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, whi...
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    FDA Sends Form 483s to Lupin, Aurobindo and Cipla Sites

    Following inspections in late September, India-based generic drugmakers Lupin, Aurobindo and Cipla received Form 483s posted last week by the US Food and Drug Administration (FDA) for observations related to cleanliness, investigations into out-of-specification results and other deficiencies. Lupin’s site in Tarapur, India was inspected over five days in late September, and the partially redacted 483 includes three observations. The first questions the company’s investi...
  • ReconRecon

    Recon: FDA Approves Lilly's Acute Migraine Drug Reyvow; J&J, Bayer's Xarelto Picks up its 8th Indication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer posts detailed phase 3 data on its Dupixent rival ( Fierce ) ( Endpoints ) ( Press ) FDA approves Eli Lilly drug to ‘resolve’ migraine pain in 2 hours ( CNBC ) ( Reuters ) ( FDA ) ( Press ) OxyContin maker Purdue gets brief shield from litigation ( Reuters ) ( NYTimes ) J&J, Bayer's Xarelto scores FDA nod to treat acutely ill patients during and after h...
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    CBO: Pelosi Bill Will Save Hundreds of Billions, Reduce Number of New Drugs to Market

    The Congressional Budget Office (CBO) late Friday announced that House Speaker Nancy Pelosi’s (D-CA) drug pricing bill would reduce federal direct spending for Medicare by $345 billion from 2023 to 2029, but it would also lead to a reduction of approximately 8 to 15 new drugs coming to market over the next 10 years. The CBO report comes as rhetoric on both sides of the aisle has picked up in recent weeks, with industry group PhRMA referring to the bill, known as HR 3, a...
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    Classifying Software Under MDR, IVDR: New Guidance From MDCG

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The guidance discusses certain types of software that would be classified under MDR or IVDR, such as software that can directly control a (hardware) medical device (e.g. radiotherapy treatm...