• Regulatory NewsRegulatory News

    Drug Regulators Look to Harmonize How They Tackle Innovation

    The International Coalition of Medicines Regulatory Authorities (ICMRA) recently released a report on how various regulators worldwide are working together to better identify and address future regulatory challenges posed by new categories of therapeutics, like cell and gene therapies, and new tools for drug development, such as artificial intelligence (AI). The report, which is part of a wider effort to reduce duplicative work and increase harmonization among drug regu...
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    FDA Chief of Staff Calls OTC Monograph Reform a Top Priority

    In a speech at the Consumer Healthcare Products Association’s Regulatory, Scientific and Quality Conference on Tuesday, US Food and Drug Administration (FDA) Chief of Staff Lauren Silvis said the agency is committed to boosting access to safe and effective nonprescription drugs.   In the US, nonprescription drugs can be marketed by conforming to an over-the-counter (OTC) monograph or via the new drug application (NDA) pathway.   “On the monograph side, I want to ma...
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    FDA Warns Orthopedic Implant Manufacturer Over Quality System Violations

    The US Food and Drug Administration (FDA) issued a warning letter to Orchid Orthopedic Solutions over violations linked to the agency’s quality system regulation, including inadequate complaint handling procedures. The warning letter cites a total of six violations. These became significant violations after the manufacturer of orthopedic implants failed to ease the agency’s concerns initially noted in a Form 483, following a 12-day inspection in February at the company’...
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    FDA Updates Mortality Rate Linked to Heart Pump in Post-Approval Study

    Patients in a post-approval study (PAS) for Abiomed’s heart pump Impella RP reported lower survival rates when compared to premarket studies, the US Food and Drug Administration (FDA) reported Tuesday. The update from the latest PAS report indicates 28.6% (12 out of 42 patients) met the primary survival endpoint, which compares with 17.4% (4 out of 23 patients) reported in February. Despite the higher rate of mortality, FDA said that when the device is used “for th...
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    FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

    A week after finalizing guidance on developing interchangeable biosimilars, the US Food and Drug Administration (FDA) has drafted guidance for biosimilar developers on the use of comparative analytical studies that can be used to assess whether a proposed product is biosimilar to a reference product. The 28-page draft guidance revises a final guidance from 2015 on quality considerations for demonstrating biosimilarity and serves as a replacement for a 2017 draft gui...
  • ReconRecon

    Recon: Merck to Buy Peloton for $1.1B to Boost Cancer Pipeline

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck agrees $1bn deal to buy biopharmaceutical company Peloton ( Financial Times ) ( WSJ ) ( Reuters ) ( Endpoints ) ( Law360 -$) ( Press ) Merck's Keytruda fails as monotherapy in breast cancer study ( Reuters ) ( Endpoints ) ( PMLive ) ( Press ) Generic drug price-fixing suit is akin to earlier case, but ‘on steroids,’ Conn. prosecutor says ( STAT ) ( PBS ) ...
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    Asia Regulatory Roundup: TGA Releases Advertising Breach ‘Stop Clock’ Policies as Legal Case Advances

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Releases Advertising Breach ‘Stop Clock’ Policies as Legal Case Advances   Australia’s Therapeutic Goods Administration (TGA) has discussed when it will stop the clock in its handling of complaints about advertising. TGA updated its policy on the same day as it shared new details of its legal case against Peptide Clinics Australia.   The original TGA guide to...
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    SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case

    In cases where state failure-to-warn claims should be dismissed as pre-empted by federal law, the Supreme Court on Monday unanimously ruled that judges, rather than juries, are better equipped to evaluate the nature and scope of an agency’s, such as the US Food and Drug Administration (FDA), determination. While ruling that a lower court should re-assess its decision on the Merck case related to the labeling for a drug’s side effects, the majority opinion also noted: “[...
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    FDA Officials Explain When Litigation Can Impact Drug Safety Signals

    The submission of litigation-associated adverse event reports (LARs) to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) can have an impact on detecting safety signals, Monica Muñoz and Gerald del Pan of FDA’s Office of Surveillance and Epidemiology wrote recently in a research letter to the journal Drug Safety . The letter came in response to a study in the same journal that found lawyer-submitted reports in FAERS did not meaningful...
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    UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

    In preparation for the future of clinical trials under EU Clinical Trial Regulation 536/2014, the UK has been running a pilot program for a little more than a year to streamline the submission and review process for applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs). Under the pilot, which has been run jointly since April 2018 by the UK’s Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA), a sin...
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    Groups Seek More FDA Flexibility in Early Cell Therapy Development

    A new white paper from the Friends of Cancer Research (FOCR) and the Parker Institute for Cancer Immunotherapy calls on the US Food and Drug Administration (FDA) to ease clinical and manufacturing requirements to speed early development of anti-cancer cell therapies.   In recent years cell therapies, including engineered T-cell receptor (TCR) and chimeric antigen receptor (CAR) T-cell therapies have shown promise in treating a wide range of cancers. To date, FDA has ap...
  • ReconRecon

    Recon: Canadian Fund Buys Keytruda Rights from UK's LifeArc for £1B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gates-backed Schrödinger raises $110m for new drug push ( Financial Times ) ( Fierce ) Exit Of No. 2 At Amazon’s Haven Keeps Walmart Employee Health Strategy In Lead ( Forbes ) ( STAT ) Dana-Farber prevails in immunotherapy dispute over patents behind blockbuster drug ( STAT ) ( Endpoints ) Commentary: We need to make sure new drug cures don’t widen income gap...