• Regulatory NewsRegulatory News

    Rare Pediatric PRV Program Not Linked to Uptick in New Drugs Starting Trials, Study Finds

    The rare pediatric priority review voucher (PRV) program was not found to be associated with an increase in the number or rate of new rare pediatric disease drugs that began clinical trials, a Health Affairs study found. But the researchers from Harvard Medical School, working on what they said is the first study on the impact of the rare disease PRV program on drug development, also found that their data do provide some encouraging news about rare pediatric disease d...
  • Regulatory NewsRegulatory News

    Industry Calls for Metrics on CDRH’s Breakthrough Device Program

    A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority review program run by FDA’s Center for Devices and Radiological Health (CDRH). The webinar led by Maureen Dreher, policy analyst at CDRH’s Office of Device Evaluation, underscored the need for additional transparency around the Breakthrough Device Program. This request was supported across several participants during the ...
  • Regulatory NewsRegulatory News

    EMA Recommends When Drugmakers Should Consult With Pediatric Research Network

    The European Medicines Agency (EMA) on Monday released recommendations from its European network of pediatric research (Enpr)-EMA working group on opportunities during various stages of development to consult with pediatric research groups.   “Enpr-EMA suggests that all companies consider using these opportunities in a spirit of shared learning about the best way to collaborate during [pediatric investigation plan] planning,” EMA writes, noting that companies can benef...
  • Regulatory NewsRegulatory News

    Health Canada Proposes Changes to Priority Review Requests for Medical Devices

    Health Canada intends to modify its policy for medical device manufacturers to request priority reviews by nixing its requirement on a separate submission and adding a new required criterion for eligibility. The existing process for medical device manufacturers to request priority reviews for expedited entries to the Canada market is “still relevant” but “unnecessarily complex,” Health Canada argued in a recent notice of intent. The conclusion was reached based on a ...
  • Regulatory NewsRegulatory News

    FDA Lists 205 Molecular Targets for Pediatric Cancer Research

     To help with anti-cancer drug development, the US Food and Drug Administration (FDA) has developed two new lists of molecular targets to guide submissions for pediatric study plans.   The two lists, posted Tuesday by FDA’s Oncology Center of Excellence, are aimed at fostering the development of new oncology drugs or biologics for pediatric populations. They also fulfill a commitment the agency made under the FDA Reauthorization Act of 2017 (FDARA).   One list po...
  • Regulatory NewsRegulatory News

    CDRH Drafts New Framework to Create a Pediatric Device Safety Network

    A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical devices, Vasum Peiris, Chief Medical Officer for pediatrics and special populations at the Center for Devices and Radiological Health (CDRH), told Focus . The new framework is “centered around the fundamental issue of safety for children,” Peiris said, posing the question “where can we actually innovate safely?” Pediatric academic medic...
  • Regulatory NewsRegulatory News

    FDA Drafts PRV Guidance for Medical Countermeasures

    The US Food and Drug Administration (FDA) on Wednesday released new draft guidance to help companies understand how the agency will award priority review vouchers (PRVs) for qualifying medical products to diagnose, prevent or treat diseases or conditions associated with chemical, biological, radiological and nuclear (CBRN) threats and emerging infectious diseases. The draft, featuring 29 questions and answers on the new PRV program, is part of FDA’s implementation ...
  • 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...