• Regulatory NewsRegulatory News

    Experts Call for New Regulatory Pathways for Antibiotics

    Faced with the increasing threat of antimicrobial resistance (AMR), experts are calling for more incentives to boost investment in new antibiotics. At the FDA/CMS Summit in Washington, DC today, representatives from several companies developing new antibiotic treatments said that while recent initiatives such as the Generating Antibiotics Now Act (GAIN Act) have helped revitalize investment in antibiotic development, more needs to be done to encourage research and deve...
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    FDA Calls Out Pathway Genomics for Marketing Unapproved Cancer Test

    Pathway Genomics is currently marketing an unapproved screening tool, which the US Food and Drug Administration (FDA) believes to be a medical device, for the early detection of up to 10 different cancer types, the agency said in a letter to the company this week. FDA says that the non-invasive blood test, known as CancerIntercept Detect, "appears to meet the definition of a device" as the company ships blood collection tubes, a medical device, for use with the tool. "W...
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    FDA Grants Approval to New Drug Under Rarely Used Animal Rule Pathway

    A new drug approved by the US Food and Drug Administration (FDA) to treat patients afflicted with the plague was reviewed under a rarely used regulatory pathway meant to sidestep ethical and practical testing concerns. Background In 2002, FDA passed the  Animal Efficacy Rule  ("Animal Rule"), a regulation which permits the approval of some products based on safety testing in humans and efficacy testing in animals. The rule, located at  21 CFR 314.600-650  (drugs) and  ...
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    New FDA Program to Expedite the Approval of 'Breakthrough' Medical Devices

    The US Food and Drug Administration (FDA) has put the finishing touches on two policies intended to expedite access to potentially life-saving devices meant for patients with life-threatening diseases or conditions. Background FDA's Center for Devices and Radiological Health (CDRH) has for several years been putting the finishing touches on two conceptually related guidance documents: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for U...
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    Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

    In recent years, the US Food and Drug Administration (FDA) has made great advances in the review of new drugs. The US now is reported to lead the world in both timeliness and quantity of noteworthy new drug approvals. 1 This trend is due in part to FDA’s ongoing commitment to improve the drug development process and establish robust, efficient and predictable development programs. As a result, products demonstrating a positive benefit-risk profile and appropriate e...
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    Six Drugs Selected to Advance in EMA's Adaptive Pathways Pilot Program

    The European Medicines Agency (EMA) recently announced that it has selected six drugs to move forward in its adaptive pathways (formerly adaptive licensing) pilot program. Background In March 2014 EMA announced it would be launching an adaptive pathways pilot program that would seek to accelerate patient access to drugs intended to treat serious unmet medical needs. The adaptive pathways program would allow drugs to receive approval for use with a narrow indication o...
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    Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals

    New legislation would allow the US Food and Drug Administration (FDA) to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria. A Limited Population Pathway The bill, the Promise for Antibiotics and Therapeutics for Health (PATH) Act , was introduced on 10 December 2014 by Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT). At its core, the legis...
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    FDA Flexes New Inspection Authority, Banning Company After it Refuses to be Inspected

    The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators. The company, Beijing Shunxin Meihua Bio-technical Co., was placed on import alert by FDA on 22 July 2014. FDA's import alerts—one for refusing inspection , and the other for failing to operate according to good manufacturing practi...
  • CFDA Announces Expedited Review Process for Innovative Devices

    The China Food and Drug Administration (CFDA) announced on 7 February 2014 the implementation of a new expedited priority review and approval process for innovative medical devices, to take effect as of 1 March 2014. The CFDA stressed that the expedited procedure would not lower existing review and approval standards, but instead would expedite the marketing of new innovative medical device technologies. The new process is also expected to promote the research and dev...
  • FDA Proposes 'New Pathway' to Approve Drugs for Unmet Needs

    The US Food and Drug Administration (FDA) plans to hold a public meeting in February to discuss the formation of a "potential new pathway" intended to bring to market new products aimed at treating serious or life-threatening conditions for which there is an unmet need. The new pathway seems likely to take advantage of FDA's new draft guidance on enriched clinical trials , which states that small, targeted subpopulations of patients may be used as the basis of approval ...
  • FDA Beefs up Medical Countermeasure Program with new 510(k) Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry regarding the development of In Vitro devices capable of detecting the presence of several types of dangerous pathogens, its latest effort in a long-running strategy to develop medical countermeasures (MCMs). The guidance, released 9 November 2012, specifically addresses the unique needs of conducting clinical trials on such a device. The clinical testing of products used to tr...
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    Approval of Jakafi (ruxolitinib) Based on a Home-Grown, Patient-Reported Outcome Instrument: A Case Study

    Jakafi® (ruxolitinib) was approved 1 by the US Food and Drug Administration (FDA) on 16 November 2011 for the treatment of intermediate or high-risk myelofibrosis (MF) including primary MF, post-polycythemia vera MF (PPV-MF) and post-essential thrombocythemia MF (PET-MF). Prior to this time, there were no approved products, and therefore no precedent for regulatory endpoints in this orphan disease. MF is a highly symptomatic 2 myeloproliferative neoplasm (MPN), cha...