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  • Regulatory NewsRegulatory News

    House E&C Offers Recommendations to Improve 340B Drug Pricing Program

    The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues and recommendations to improve the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients. The 80-page report follows an October House E&C hearing in which hospital executives pushed back on the idea that the 340B program should be narrowed o...
  • Regulatory NewsRegulatory News

    Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds

    Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ. Researchers from New York University, Yale, Stanford and the International AIDS Vaccine Initiative reviewed data from more than 45 sources on 505 trials for 14 drugs approved by the US Food and Drug Administration (FDA) in 2014. "On the drug level, about half of FDA-approved drugs have publicly ...
  • Regulatory NewsRegulatory News

    Apple, Verily and J&J Among 9 Selected for FDA Digital Health Pilot

    US Food and Drug Administration Commissioner Scott Gottlieb took the stage Tuesday at AdvaMed’s MedTech conference in San Jose, California, unveiling the nine companies selected among 103 applicants to participate in the agency’s precertification pilot for digital health applications. FDA  launched the pre-cert pilot  in July as part of the agency’s  Digital Health Innovation Action Plan. The pilot participants, representing a range of companies and technology in the ...
  • Regulatory NewsRegulatory News

    MedTech Industry Sees Challenges in Restarting Operations, Helping Puerto Rico

    With more than three million Americans in Puerto Rico facing no electricity because of Hurricane Maria, medical device and biopharmaceutical companies, many of which have manufacturing facilities on the island, are doing what they can to work with the US government to help their employees and restart operations. A spokesman from MedTech industry group AdvaMed told Focus at the group’s MedTech conference in San Jose, California on Monday that the group is working w...
  • Regulatory NewsRegulatory News

    Congress Sets Sights on Pharma Cybersecurity After Attack

    Leadership from the House Energy and Commerce (E&C) committee on Wednesday called on Merck CEO Ken Frazier and Department of Health and Human Services Secretary (HHS) Tom Price to brief Congress on the impact of a recent cyberattack on the healthcare sector. Background On 27 June, a cyberattack involving ransomware known as "Petya" or "NotPetya" infected government and business computer systems in Ukraine before spreading to other corporate networks around the world. M...
  • Feature ArticlesFeature Articles

    Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices

    This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy. Introduction Bringing new and innovative medical technologies to the US market has numerous challenges, including market identification, product development, regulatory and quality requirements, and demonstrating both clinical and economic effectiveness. In recent years, adequate reimbursement has beco...
  • Regulatory NewsRegulatory News

    House to Consider MDUFA Add-Ons

    With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package. On Tuesday, the E&C subcommittee will discuss four bills that look to make hearing aids more accessible to patients over-the-counter , overhaul FDA's inspection program for device establishments , ...
  • Regulatory NewsRegulatory News

    Cybersecurity: House Committee Looks to Build on Public-Private Partnerships

    The House Energy & Commerce Committee on Tuesday held a hearing looking into ways to improve cybersecurity across the healthcare sector. In recent years, cybersecurity has been a growing concern in healthcare, with high profile cyber-attacks and vulnerabilities causing disruptions for insurers , hospitals and medical device makers . The stakes for patients are high too as patient data could be lost or tampered with, hospital services interrupted or patients harmed t...
  • Regulatory NewsRegulatory News

    FDA Office of Regulatory Affairs Realignment to Begin in May

    The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren. Shuren made the announcement to members of the House Energy & Commerce Committee on Tuesday at a hearing on the Medical Device User Fee Amendments , which must be reauthorized by 30 Septemb...
  • Regulatory NewsRegulatory News

    FDA and CMS Parallel Reviews of Devices to Continue

    A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday. The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or t...
  • Regulatory NewsRegulatory News

    FDA Hits Valeant’s Bausch & Lomb With Form 483

    The US Food and Drug Administration (FDA) on Tuesday released a Form 483 for Valeant’s Bausch & Lomb sterile drug manufacturing facility in Tampa, FL, citing the site for microbiological contamination of drugs purporting to be sterile. The eight-day inspection last February uncovered four observations detailing : Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up Procedures designed to prevent microbiological...
  • RAPS' LatestRAPS' Latest

    RAPS' Scope of Practice Survey Shows Regulatory Pros Play Increasingly Strategic Role Compensation Up

    RAPS today released the results of its biennial survey of healthcare product regulatory professionals around the world. The survey asked respondents about their daily work, education and professional backgrounds, and compensation. RAPS has compiled and published key survey results and analysis in its 2016 Scope of Practice & Compensation Report for the Regulatory Profession , which can be downloaded at www.RAPS.org/sop . Among the most significant findings, r...