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  • Regulatory NewsRegulatory News

    FDA Briefing Documents Offer Support for Remicade Biosimilar

    The US Food and Drug Administration (FDA) on Friday unveiled briefing documents that could support the approval of Celltrion’s proposed Remicade (infliximab) biosimilar ahead of next Tuesday’s advisory committee hearing. The 73-page document offers new insight into what Celltrion submitted to support the licensure of its biosimilar, known as CT-P13, for Johnson and Johnson’s reference product, and FDA officials noted that the two products are “highly similar,” though th...
  • Feature ArticlesFeature Articles

    510(k) Submissions: Current Trends and Tips

    This article discusses current trends in the 510(k) submission process, primarily with Class II orthopedic and spinal implants, and will provide tips on maintaining a smooth and successful submission process. This past year has seen the 510(k) submission process evolve and the US Food and Drug Administration (FDA) take a more stringent stance on what submission materials will be accepted. To offset some of the technical impact of a stricter adherence to a more rigorous...
  • Feature ArticlesFeature Articles

    The 'Catch-Up' 510(k) - A Submission Often Overlooked

    This article discusses "catch-up" 510(k) submissions, circumstances under which a "catch-up" 510(k) submission should be considered, content and timing of such a submission and procedural recommendations for this submission type. Background The majority of medical devices are brought to market in the United States through the 510(k) pathway. A 510(k) clearance is based on FDA's review and concurrence with the submitter's substantial equivalence determination, allowin...
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    Facilities Sterilizing Devices via 'Novel' Methods Will See New FDA Inspections

    As medical devices are sterilized with novel and sometimes risky new methods and chemical combinations, the US Food and Drug Administration (FDA) announced Wednesday that it will begin inspecting companies' manufacturing facilities before clearing their 510(k) applications. The shift in FDA’s thinking comes as the agency says in Wednesday’s final guidance, issued more than seven years after the draft document was released, that it’s received “an increasing number of 510(...
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    FDA Likely to Require Substantial Clinical Data for Interchangeable Biosimilars, Lawyers Say

    The US Food and Drug Administration (FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, though the question of how much data will be required is major factor in determining how quickly the US biosimilars market will take off, according to a new report from the law firm Goodwin Procter. The Biologics Price Competition and Innovation Act (BPCIA) of 2010 established th...
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    FDA Sees Record-High PMA Approval Rate for 2015

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015 and the spike may be linked to FDA’s improved assessment of PMA deficiencies earlier in the review process. The 98% approval rating in 2015 for PMAs is the highest FDA has seen in at least 15 years, and 8% higher than the next highest from 2005, according to a 371-page quarterl...
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    Senators Introduce Two Bills to Streamline FDA Reviews of Medical Devices

    Sens. Cory Gardner (R-CO) and Joe Donnelly (D-IN) late Wednesday announced the introduction of two new bills that would further streamline the US Food and Drug Administration (FDA) approval process for certain medical devices. One of the bills -- the Rare Device Innovation Act -- would expand the threshold by which FDA could approve medical devices that treat rare diseases, including ALS, cerebral palsy, Hodgkin’s lymphoma, mesothelioma and tuberculosis. Currently, FDA...
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    FDA Workload, Spending on Biosimilars Program Picks Up in 2015, Report Says

    In the first two and a half years of the US Food and Drug Administration (FDA)’s biosimilars review program, the agency is only recently starting to ramp up spending and manpower, according to an interim report from Eastern Research Group (ERG) released Wednesday. Background Under the Biosimilar User Fee Act (BsUFA), enacted by Congress in 2012, FDA was required to contract with an independent consulting firm to develop an estimate of the workload volume and full costs ...
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    OpenFDA Releases Huge Trove of Medical Device Data

    On Monday, the US Food and Drug Administration (FDA) released a vast amount of medical device data to its openFDA platform. Background The openFDA initiative was originally born from an order from the White House , which called for federal agencies to implement a new " digital strategy " to make government information more accessible to the public. The strategy focused on creating APIs – not active pharmaceutical ingredients, but application program interfaces – that ...
  • Regulatory NewsRegulatory News

    Are You a Good Witch, or a Bad Witch?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.  The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Upon meeting Dorothy in The Wizard of Oz, Good Witch Glinda asks “Are you a ...
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    Eight Additional Device Classes Exempt from Premarket Notification Requirements

    In July, the US Food and Drug Administration exempted some 120 medical device classes from its premarket notification and review requirements. Now, FDA has announced it is exempting additional device classes from these requirements, after an administrative error caused the agency to miss some comments from a public consultation. Background In 2012, during the third Medical Device User Fee Act (MDUFA) talks, FDA committed to reducing regulation on certain low-ris...
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    FDA Updates Refuse to Accept Policy for 510(k)s

    This week, the US Food and Drug Administration (FDA) released a new guidance detailing its criteria for accepting 510(k) submissions. The new Refuse to Accept Policy for 510(k)s , which takes effect on 1 October 2015, will take precedence over three previous documents, the 2012 Refuse to Accept Policy for 510(k)s , 510(k) Refuse to Accept Procedures (K94-1) blue book memo and Premarket Notification (510(k)) Refuse to Accept Policy which were released in 2012, 199...