• FDA Publishes All User Fee Rates for Fiscal Year 2014

    The US Food and Drug Administration (FDA) has just published the user fee rates set to go into effect for the coming 2014 fiscal year (FY), including those for pharmaceuticals, biosimilars, facilities, master files, generic drugs and medical devices. Background Since the early 1990s, FDA has become increasingly reliant upon user fees to fund its operations. Whereas before the agency relied almost entirely on federal funding to conduct its operations, now nearly all indu...
  • In Response to MDUFA Commitments, FDA Prepares to Make Changes to IDE Submission System

    Medical device regulators at the US Food and Drug Administration (FDA) are planning to unveil a new technology platform in August 2013 through which industry will be expected to submit clinical trial requests, the agency announced today. The change is occurring as a result of FDA's commitments to industry under the Medical Device User Fee Act of 2012, a subset of the Food and Drug Administration Safety and Innovation Act (FDASIA) . As outlined in a commitment letter a...
  • As FDASIA Celebrates First Year, FDA Says Drugs, Devices Already Seeing Benefit

    On 9 July 2012, US President Barack Obama quietly signed into law a piece of legislation that had received overwhelming support in both chambers of Congress - a relative rarity in the hyper-political 112 th Congress. That law, the Food and Drug Administration Safety and Innovation Act (FDASIA) , is now one year old, and the US Food and Drug Administration (FDA) is marking the occasion by talking about what it's been doing to implement the considerable number of provisio...
  • New FDA Guidance Clarifies Process for Submission of Device User Fees

    A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user fees to the agency in return for the processing of their premarket approval (PMA) applications and device biologics license applications (BLAs). Background In July 2012, President Barack Obama signed into law the FDA Safety and Innovation Act (FDASIA) , which, among other ...
  • 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 ...
  • FDA Authorized to Spend New User Fees Under Just-Passed Senate Bill

    The US Senate has approved  a measure that would both continue funding government agencies at their currently-appropriated levels and grant the US Food and Drug Administration (FDA) access to user fees it is already authorized to collect, raising the possibility that US regulators will soon be given access to much-needed funding. The bill, known as the continuing resolution (CR), is needed to prevent a potential government shutdown that will otherwise occur at the ...
  • MDUFA Goals Met in 74-85% of Cases in 2012, FDA Report Says

    The US Food and Drug Administration (FDA) has released a new congressional report it wrote regarding its performance under the final fiscal year of the Medical Device User Fee Act (MDUFA) , a law intended to help the agency access more funding in return for meeting more stringent timelines for the review of medical devices. The second iteration of the act, MDUFA II , was passed in 2007 under the Food and Drug Administration Amendments Act (FDAAA) , and contains numero...
  • Legislation Corrects User Fee Oversight for Medical Devices, Generic Drugs

    Legislators have introduced a piece of legislation in the US House of Representatives that would allow the US Food and Drug Administration (FDA) to spend user fees that it had previously been able to collect, but unable to spend. The appropriations bill, introduced on 4 March 2013 by Rep. Hal Rogers, chairman of the House Appropriations Committee, would fund the government to the tune of $982 billion through 30 September 2013, when-in theory-legislators should be able to...
  • Sebelius Writes to Congress, Reminding Them of Sequester's Impact on User Fees

    US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius has quietly confirmed what many in the industry have long known: User fees paid to the US Food and Drug Administration (FDA) under various legislative vehicles and agency programs are at risk under the sequester. Background On 1 March 2013, without intervention from Congress, all federal agencies (with the exception of the Department of Defense) will be subjected to an annualized 8% reduction ...
  • FDA Says Hurricane Sandy Will Affect Review Target Dates, Regulated Industry

    Hurricane Sandy left much of the US' eastern seaboard battered and flooded after coming ashore in late October, and the damage and delays it caused are having regulatory implications, the US Food and Drug Administration (FDA) said in an announcement. In a 1 November 2012 statement , FDA Commissioner Margaret Hamburg said her agency was heavily focused on the storm and its potential to affect regulated industry. "We often think of major storms like Sandy in terms of th...
  • CDRH’s Zimmerman Provides Update on Progress, Planned Changes under MDUFA III

    The third and latest iteration of the Medical Device User Fee Act may be the most important yet, said panelists participating in a discussion at 2012 RAPS in Seattle, WA. The act, known colloquially as MDUFA III , was passed into law in July 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) , a sprawling piece of healthcare legislation that looks to overhaul and enhance many of the US Food and Drug Administration's (FDA) processes an...
  • MDUFA Guidelines on FDA Review Time and Goals Released

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released two new guidance documents pertaining to how the agency plans to calculate review time and goals for medical device submissions under the Medical Device User Fee Act (MDUFA) , part of the FDA Safety and Innovation Act (FDASIA) . Specifically, the guidance documents reference two of the most common forms of medical device submissions: 510(k) applications, which are...