• Feature ArticlesFeature Articles

    From real-world data to real-world evidence: An interregional perspective

    In recent years, data generation in clinical practice outside clinical trials has grown exponentially, largely because of an increase in the number of advanced signal detection technologies, including sensors, imaging, measurements, and mobile devices. At the same time, database capabilities have also expanded because of advances in storage technology. As a result of the innovative digitalization of the collection of real-world data (RWD) together with artificial intellige...
  • Regulatory NewsRegulatory News

    Pazdur mounts defense of accelerated approval during Cures 2.0 panel

    During a listening session convened by the Friends of Cancer Research (FOCR) with Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) on their nascent Cures 2.0 package, Richard Pazdur, director of the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) defended the agency’s accelerated approval program.   (RELATED: Cures 2.0: Discussion draft signals impact on FDA, creation of ARPA-H , Regulatory Focus 23 June 2021)   Asked by DeGette w...
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    Another drug firm faces potential fines for research non-reporting

    A small Georgia pharmaceutical company has received a notice of noncompliance from the US Food and Drug Administration (FDA) for not registering clinical trial results in a central government registry, as required by federal law.   The 26 July letter is the second issued by FDA for noncompliance with federal research reporting requirements outlined in Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). If results are not reported within on...
  • Regulatory NewsRegulatory News

    Industry groups want more time to comment on FDA's track and trace guidance

    Two groups representing pharmaceutical manufacturers, wholesalers and distributors say they need more time to review draft guidance from the US Food and Drug Administration (FDA) calling for the establishment of electronic systems for tracking products through the supply chain.   Such systems are called for under the Drug Supply Chain Security Act (DSCSA). One group said industry would have major challenges if the draft was finalized; the groups are calling for the dea...
  • Regulatory NewsRegulatory News

    FTC to focus enforcement action on illegal repair restrictions

    In a unanimous vote, the Federal Trade Commission (FTC) has decided to focus law enforcement efforts on repair restrictions that impede or prevent consumers and businesses from repairing products they own.   “While unlawful repair restrictions have generally not been an enforcement priority for the Commission for a number of years, the Commission has determined that it will devote more enforcement resources to combat these practices,” FTC said in a new policy statemen...
  • ReconRecon

    Recon: US authorities probing Emergent over vaccine issues; Japan authorizes AstraZeneca vaccine after delay

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden pushes cash reward to get vaccinated, new rules for federal workers ( Reuters ) US authorities probing Emergent BioSolutions over COVID-19 vaccine issues- filing ( Reuters ) Cavazzoni in the hot seat: House committee grills CDER director on neuro drugs ( Endpoints ) ( STAT ) States could get billions from opioid lawsuits. They have to decide how to spend...
  • Feature ArticlesFeature Articles

    Considerations for regulatory application of RWD-generated external comparators

    Properly designed and analyzed external comparators (ECs) built from real-world data (RWD) and the resulting real-world evidence (RWE) can be compared in certain situations with data generated from single-arm or traditional randomized clinical trials to support regulatory decisions. Proper development, design, and use of ECs requires more than simple matching of the clinical trial inclusion and exclusion criteria within the RWD source. A focus on the specificity of the res...
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    Preparing an NDA or MAA: The top three critical strategies for success

    My experience over the past decade managing the timelines of the marketing application preparation process has taught me two main lessons. First, no two marketing applications (NDA, BLA, NDS, MAA, etc.) projects are the same. Second, all marketing application projects can benefit from the same set of three guiding principles. Before you begin your next marketing application project, consider carefully whether you have covered these three critical bases for a succe...
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    All marketing application projects require three guiding principles

    My experience over the past decade managing the timelines of the marketing application preparation process has taught me two main lessons. First, no two marketing applications (NDA, BLA, NDS, MAA, etc.) projects are the same. Second, all marketing application projects can benefit from the same set of three guiding principles. Before you begin your next marketing application project, consider carefully whether you have covered these three critical bases for a succe...
  • Regulatory NewsRegulatory News

    FDA to Amazon: Stop shipping products that contain undisclosed drugs

    The mammoth online retailer Amazon received an untitled letter from The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) identifying 26 sexual enhancement and weight loss products that contain “undeclared” and “potentially harmful” drug ingredients, according to FDA’s testing of the products.   In this letter — not the first correspondence the agency has had with Amazon on the matter —the firm was called out for marketing unapprove...
  • Regulatory NewsRegulatory News

    EMA updates reflection paper on GMP responsibilities of marketing authorization holders

    The European Medicines Agency (EMA) on Thursday issued an updated reflection paper specifying the good manufacturing practice (GMP) responsibilities of marketing authorization holders under the European Commission (EC) GMP guidelines and other EU legislation.   The paper replaces a draft version issued in January 2020 with only some minor revisions. (RELATED: EMA Consults on GMP Reflection Paper , Regulatory Focus, 22 January 2020).   The paper covers the re...
  • RoundupsRoundups

    Euro Roundup: France posts guidance on developing drug shortage management plans

    The French National Agency for Medicines and Health Products Safety (ANSM) has released guidance on the development of shortage management plans for drugs of major therapeutic interest.   In March, France published a decree to establish an obligation for pharmaceutical companies to have buffer stocks of medicines to mitigate the risk of shortages. The amount of stock companies need to carry depends on the importance of the drug. France will require manufacturers of dru...