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  • Regulatory NewsRegulatory News

    France Begins Speeding Clinical Trial Start-Up Times

    As part of a push to more quickly offer patients access to innovative treatments, France’s drug regulator, known as ANSM, has established two “Fast Track” options that will expedite the authorization of clinical trials. Unlike the US Food and Drug Administration’s (FDA) Fast Track process, which is designed to expedite the review of drugs to treat serious conditions and fill an unmet medical need, France’s new designation concerns clinical trials of innovative treatment...
  • Regulatory NewsRegulatory News

    ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable

    The International Coalition of Medicines Regulatory Authorities (ICMRA) has its eye on aligning existing and planned track and trace systems worldwide, with a focus on interoperability as many of the existing and planned systems were designed with a national or regional focus. Track and trace systems, which have been or are currently being implemented in the US, EU, Turkey, Argentina, Canada, Italy and Japan, are used to help ensure falsified, counterfeit or otherwi...
  • Regulatory NewsRegulatory News

    Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds

    The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found a higher association with these expedited pathways and the likelihood of safety-related labeling changes than with non-expedited pathways. In their analysis of 15 years of data, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Program on Regulation, Therapeutics, And Law...
  • Regulatory NewsRegulatory News

    FDA Offers Draft Guidance to Further Secure Drug Supply Chain

    The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013. Background The DSCSA outlines the path to better secure the US drug supply chain via an electronic, interoperable system by 2023 to track and trace certain prescription drugs as they are distributed. The law helps FDA ensur...
  • Regulatory NewsRegulatory News

    Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate

    A recent study in Health Affairs suggests that drugs given an expedited review by the US Food and Drug Administration (FDA) offer greater health gains than drugs that receiving a conventional review. But experts caution that the study might only show incremental benefits. The study, conducted by Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health and three of his colleagues at Tufts Medical Center, compared the change in quality-adjuste...
  • Regulatory NewsRegulatory News

    FDA Delays Enforcement of Product Identifier Requirements

    In a draft guidance published Friday, the US Food and Drug Administration (FDA) says it does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before 26 November 2018. "This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. For the products that ...
  • Regulatory NewsRegulatory News

    Swissmedic Touts 2016 Performance: 42 New Approvals

    In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in approving new drugs in 2016, in part due to the agency's new fast-track procedure. In 2016, Swissmedic approved 42 new active substances (NASs), a 50% increase over the previous year and just over 50% more than EMA recommended. "This increase shows that the pharmaceutical industry in Switzerland is conti...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Offers Fast-Track Approvals to HIV, Hepatitis Combination Products The Drug Controller General of India (DCGI) is offering fast-track approvals to combination products to treat HIV and hepatitis B and C. DCGI Dr GN Singh is prepared to waive the need to run clinical trials and truncate the regulatory submission process to cut the time it takes for sponsors to br...
  • Regulatory NewsRegulatory News

    FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section

    The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate. Under the new section, which FDA says is being distributed “for comment purposes only,” the agency offers its interpretation of Section 582(b)(4)(B)(ii)(II) of the Food, Drugs and ...
  • Regulatory NewsRegulatory News

    Companies Collaborate on DSCSA Guideline as Deadlines Approach

    Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013. In preparation for that deadline and others over the next seven years, a diverse group of 44 companies – from manufacturers to wholesalers to solution providers – came together to develo...
  • Feature ArticlesFeature Articles

    Global Regulatory Strategy

    This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers. The term "strategy," per Merriam Webster (Edition 11), means "a careful plan or method for achi...
  • Regulatory NewsRegulatory News

    EMA Tries to Assuage Professors on Assumptions Linked to Adaptive Pathways Pilot

    The European Medicines Agency’s (EMA) Executive Director Guido Rasi and senior medical officer Hans-Georg Eichler sent a letter on Thursday to clarify some assumptions called into question by a group of nine professors who are criticizing aspects of the agency’s adaptive pathways pilot program. Background First announced in March 2014, EMA’s pilot program seeks to accelerate patient access to drugs for patients with pressing medical needs and after approval for a narrow...