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  • Regulatory NewsRegulatory News

    Formal Dispute Resolution: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Friday finalized its guidance on the system for formally disputing scientific or medical issues between a sponsor and the agency. While the guidance remains largely similar to the agency's revised draft version issued in September 2015, FDA says it has provided clarifications on several issues and updated the guidance to reflect changes to its dispute resolution goals for generic drugs under the reauthorized Generic Drug Us...
  • Regulatory NewsRegulatory News

    Industry Conflicts With FDA: The Options

    Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month. The conversation on disputes came as FDA in September further clarified and updated its guidance on how it resolves complicated medical and scientific disagreements between industry and FDA. Informal D...
  • Regulatory NewsRegulatory News

    FDA Updates Guidance on Resolving Scientific, Medical Disputes

    The US Food and Drug Administration (FDA) has further clarified and updated its guidance on the system for resolving complicated medical and scientific disagreements between drug sponsors and the agency. The draft guidance is meant for cases when a sponsor may disagree with FDA and a dispute arises. The disputes often involve complex scientific and/or medical matters, so FDA deems it critical to have procedures in place to help ensure an open, prompt discussion. The rev...
  • RAPS' LatestRAPS' Latest

    Should You Pursue a Master's Degree or a Regulatory Affairs Certificate?

    There is mounting evidence that pursuing a professional or graduate certificate may be a very savvy career investment. The popularity of certificates is on the rise. According to a 2012 study from the Georgetown University Center on Education and the Workforce, certificates are the fastest growing postsecondary credential, and second only to bachelor’s degrees in the number earned each year. About 10% of regulatory professionals now have postgraduate certifica...
  • President Signs into Law Budget Bill that Restores FDA's Authority to Spend User Fees

    A new budget resolution passed into law by President Barack Obama on Wednesday will for the first time allow the US Food and Drug Administration (FDA) to spend tens of millions of annual user fees the agency had already been authorized to collect under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, but had been unable to spend under its existing budgetary authority. Background The fees are responsible for funding a significant portion of ...
  • Proposed Senate Bill would Increase FDA Funding by $24 Million, Restore User Fee Funding

    The Senate version of a Continuing Resolution bill that recently passed the US House of Representatives would, like the House version, allow the US Food and Drug Administration (FDA) full access to user fees it now collects from generic pharmaceutical and medical device companies under the 2012 FDA Safety and Innovation Act , as well as some additional appropriated funding. The fees are responsible for partially funding the regulatory agency, which relies on them to be ...
  • Updated Draft Guidance Describes Process for Dispute Resolutions for Drug Products

    The US Food and Drug Administration (FDA) has released a new draft guidance that describes the process by which those in the biopharmaceutical industry can initiate and elevate disputes regarding drug and biological products. The guidance is intended to apply to FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the two centers responsible for the review and evaluation of nearly all of the drug and biological...
  • FDA, Feds Face Three Paths to Fiscal Calamity in Next Three Months

    Federal regulatory agencies may have breathed a collective sigh of relief on 2 January 2013, when it was clear that US legislators had struck a last-minute deal to avert the so-called " fiscal cliff " by agreeing to a number of provisions that delayed its implementation by several months. Now, several weeks later, it's beginning to feel like déjà vu all over again. That's because Congress will be facing a unique set of circumstances starting in just a few w...
  • With Cuts to FDA Looming, Congress Prepares to Adjourn--Again

    Federal programs, including those of the US Food and Drug Administration (FDA), are under seige. Under the combined terms of a proposed budget resolution and budget sequestration, FDA stands to lose hundreds of millions of dollars in both congressionally appropriated and user fee-generated funding during the 2013 fiscal year. And, with just three months left in which to restore funding to FDA, Congress is preparing to adjourn-again. The Hill reports that the Senate...
  • Budget Bill Passes House, Leaving FDA User Fees to Languish

    A budget bill passed in the US House of Representatives would, in its current form, deprive the US Food and Drug Administration (FDA) of tens of millions of dollars in funding promised to it in legislation passed earlier this year. The bill, also known as a continuing resolution (CR), would fund the government at fiscal year 2012 levels, essentially keeping in place the exact same budget that existed last year. The bill passed the House on 13 September in a 329-91 vote...
  • Legislation Would Keep FDA Budget at 2012 Levels Through March

    Legislators in the US House of Representatives and US Senate are back in session and looking to pass legislation to keep government agencies funded through March 2013. The draft legislation of a tentative agreement between Democrats and Republicans, first announced before the start of the August 2012 congressional recess, would largely maintain current funding levels across federal agencies. The government would be funded with $1.047 trillion in appropriations-$26.6 ...
  • CDRH Revises Standard Operating Procedures for Dispute Resolution

    The US Food and Drug Administration (FDA) has released an updated standard operating procedure (SOP) aimed at defining the process by which agency staff can resolve differences of opinion between staff regarding the safety or efficacy of a medical device. The SOP, entitled SOP for Resolution of Internal Differences of Opinion in Regulatory Decision-Making , was published by the Center for Devices and Radiological Health (CDRH) on 10 September 2012. The document expl...