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  • Regulatory NewsRegulatory News

    Help Wanted: FDA Seeks Digital Health Entrepreneurs

    Details of how the US Food and Drug Administration (FDA) is planning to tackle the growing digital health industry are slowly trickling out, and on Wednesday the agency announced it will establish an Entrepreneur-in-Residence (EIR) Program to support and help develop its Software Precertification (PreCert) Pilot Program. The idea is to embed these entrepreneurs for a minimum of three days per week on FDA’s White Oak campus to help analyze software business processes...
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    Early Feasibility Studies for Devices: FDA Highlights Success From Pilot

    In a paper published in the Journal of Vascular and Interventional Radiology last week, two officials from the US Food and Drug Administration (FDA) say that the agency's early feasibility study (EFS) program helped optimize the development of a new type of catheter designed to prevent pulmonary embolisms. The program is part of an effort by FDA to promote more EFSs being done in the US, as device makers often conduct such studies elsewhere before conducting later stud...
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    Professors Offer 3 Questions on FDA’s New Digital Health Framework

    The US Food and Drug Administration’s (FDA) recent push to reshape how it regulates digital health products with shifts to third-party certification and more postmarket reviews is called into question by three law professors in Health Affairs , who offer up three questions about the direction of the plan. First, the professors from Southern Methodist University, Indiana University and Harvard write that the recently passed 21st Century Cures Act does not includ...
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    FDA Offers More Details on Digital Health Precertification Pilot

    The US Food and Drug Administration (FDA) this week sought to answer some frequently asked questions regarding the rollout of its new precertification pilot program for digital health products, which is expected to begin 1 September and only include nine participating companies. The third-party certification program, first announced in June by FDA Commissioner Scott Gottlieb, will assess developers based on their software development, validation and mai...
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    FDA Updates on Digital Health Plans, Software Pre-Certification Pilot

    The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices. According to the agency's newly released Digital Health Innovation Action Plan , FDA's Center for Devices and Radiological Health (CDRH) plans to improve the landscape for digital health technologies by developing guidance on the medic...
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    FDA Launches New ORA Structure to Align Inspections With Expertise

    The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA). The move, part of FDA's program alignment , is aimed at more closely aligning the agency's inspection efforts with the various products it regulates. "Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA's centers and the industries we regulate," FDA writes. Under the agency's previo...
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    EMA-FDA QbD Pilot Program Led to Further Harmonization

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH). Background The joint pilot program, initially launched in March 2011 for three years, was extended for two more years in 2014 to facilitate further harmonization of per...
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    BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products

    Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations. Background Under what’s known as the pre-request for designation (pre-RFD) program, sponsors can ask FDA how their product will be classified (drug, device, biological product or combination product), and which of the agency's three review centers will be responsible for reviewing and reg...
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    CMS Drops Medicare Part B Drug Payment Pilot

    The Centers for Medicare and Medicaid Services (CMS) late Thursday decided to abandon a pilot plan that aimed to lower Medicare pharmaceutical spending. The Part B Drug Payment Model , first unveiled in March, would have tested whether alternative drug payment designs will lead to a reduction in Medicare expenditures. CMS said in a statement on Friday to Focus : "After considering comments, CMS will not finalize the Medicare Part B Drug Payment Model during this Adm...
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    WHO Seeks API Manufacturers for Prequalification Program

    The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health. WHO invites manufacturers of selected APIs to submit Expressions of Interest (EOIs) for API evaluation and says the ultimate aim of...
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    Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program

    The House late Tuesday followed its Senate counterparts and sent to President Barack Obama a re-authorization of the rare pediatric disease priority review voucher (PRV) program that will last through the end of December. A spokeswoman for Sen. Bob Casey (D-PA), a sponsor of the bill, told Focus that between now and 30 December, Congress will discuss ways to amend the program and extend it again. “Our policy changes are in S. 1878, which is headed to the president, so...
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    EMA to Continue Adaptive Pathways Program as Pilot Ends

    The European Medicines Agency (EMA) on Wednesday published a final report on its experience from its adaptive pathways pilot project, noting that a few aspects of the program need to be further improved and refined moving forward.  Though the vast majority of applications for the pilot were rejected, EMA said that moving forward, the agency needs to further integrate the patient voice into the program and refine the definition of methodologically sound strategies for col...