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  • Regulatory NewsRegulatory News

    FDA Proposes Rule for Appealing CDRH Decisions

    The US Food and Drug Administration (FDA) on Tuesday proposed a new rule for appealing certain decisions about medical devices made by the Center for Devices and Radiological Health (CDRH). The proposed rule is in line with legislative requirements established by the Food and Drug Administration Safety and Innovation Act(FDASIA) and 21st Century Cures Act (Cures) for clarifying procedures and timeframes for appeals of "significant decisions" to CDRH. Section 517A of...
  • Regulatory NewsRegulatory News

    Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says

    Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they? Jeff Shuren, director of CDRH late Monday told attendees of JP Morgan’s annual conference that he thinks fear and a limited amount of CMS staff are two reasons that the parallel review ...
  • Regulatory NewsRegulatory News

    FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP

    Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval. Multiple review cycles has been an outstanding challenge for the agency in years past, with less than 10% of ANDAs winning ap...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Adopts Guidance on Device Priority Review Pathway (2 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Adopts Guidance on Medical Device Priority Review Pathway Australia’s Therapeutic Goods Administration (TGA) has adopted guidance on its priority review pathway for medical devices. The adoption of the guidance allows developers of highly promising devices aimed at serious unmet needs to jump to the front of the queue when they file for approval. Devices must mee...
  • Regulatory NewsRegulatory News

    FDA Closes Loophole Companies Used to Skirt Pediatric Study Requirements

    The US Food and Drug Administration (FDA) on Tuesday released draft guidance indicating that it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases except for under certain conditions. Those conditions are if the use of the drug in the pediatric subpopulation are for a valid orphan subset, meaning "that use of the drug in a subset of persons with a non-rare disease or condition may be appropriate but use of th...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Critical Moment for EMA (15 December 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Commission Creates Roadmap for Evaluation of Pediatric Rare Disease Legislation The European Commission has created a roadmap for evaluating legislation covering pediatric rare diseases. Officials are embarking on the nearly two-year evaluation to understand why regulations on pediatric and orphan medicines have failed to translate into the hoped-for medical advances. ...
  • Regulatory NewsRegulatory News

    Have PRVs Incentivized New Rare or Neglected Disease Research? Experts Discuss

    The priority review voucher (PRV) programs, created by Congress with an eye to incentivizing the development of new rare pediatric and neglected tropical disease drugs, have so far rewarded a wide range of small and large biopharma companies and products, though whether PRVs have actually spurred new research remains a question. Andrew Robertson, head of regulatory science and policy at Sanofi, and Rachel Cohen, regional executive director for the Drugs for Neglect...
  • Regulatory NewsRegulatory News

    More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance that could help speed the development of treatments for rare pediatric disease drugs. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said the draft guidance "could eliminate the need for certain clinical studies and, when pediatric clinical studies are needed, could reduce the total number of patients who would receive a placebo instead of a potentially helpful...
  • Regulatory NewsRegulatory News

    FDA Finalizes Chagas Disease Guidance for Blood Collection Establishments

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on the use of serological tests to reduce the risk of transmission of T. cruzi , a parasite that causes Chagas disease, in blood and blood components. This guidance supersedes 2010 guidance and finalizes a draft from 2016 that amended the 2010 guidance by expanding its scope to include the collection of blood and blood components for use in manufacturing a product, including donations intende...
  • Regulatory NewsRegulatory News

    FDA, CMS: Second Parallel Review Decision Ever for NGS Test

    The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test. The test was reviewed under FDA and CMS' parallel review program, and is only the second test to be approved and cleared under the program since its inception in 2011, the first being Exact Sciences' Cologuard colorectal cance...
  • Regulatory NewsRegulatory News

    As Transparency on Priority Review Vouchers Fades, Prices Level Off

    In the early days of the priority review voucher (PRV) programs, back in 2014 and 2015, companies publicly disclosed who they sold their PRVs to, how much they cost and which products they were eventually used to speed the review of. But now that 17 PRVs have been issued by the US Food and Drug Administration (FDA), news of PRV sales has slowed to a trickle of SEC filings and the rare press release. Three times already in 2017, with GlaxoSmithKline and Teva’s...
  • Feature ArticlesFeature Articles

    Shaking Palsy, aka Parkinson's Disease, is Still a Mystery

    This article discusses disease etiology, history and symptoms of Parkinson's disease as well as ongoing research and new treatment options. Introduction There are hundreds of diseases named after a person. These are called "eponymous diseases," and a small sample includes Crohn's disease, Salmonellosis, Huntington's disease, Hodgkin's lymphoma, Lou Gehrig's disease, Tourette's syndrome and the well-known Alzheimer's disease and Parkinson's Disease (PD). PD is one of...