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    FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

    The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV). In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a n...
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    FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018

    With the new user fee deals signed into law, the US Food and Drug Administration (FDA) on Wednesday unveiled the revamped fee amounts that will apply from 1 October 2017 to 30 September 2018 for prescription drug and biosimilar application and programs. For prescription drugs requiring clinical data, the price for FY 2018 will be about $2.4 million, which is nearly $400,000 more than in 2017. For prescription drugs not requiring clinical data, the fee will be about...
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    Congress Takes First Look at User Fee Program for OTC Drugs

    The House Energy & Commerce committee on Wednesday held its first hearing on a bill to reform the US Food and Drug Administration's (FDA) over-the-counter (OTC) drug monograph process by creating a new user fee program and offering marketing exclusivity for innovations to monograph products. A bipartisan discuss draft of the bill, developed by Reps. Bob Latta (R-OH), Diana DeGette (D-CO), Brett Guthrie (R-KY), Debbie Dingell (D-MI), Gene Green (D-TX) and Subcommittee o...
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    Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018

    Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements. For instance, device companies submitting 510(k) applications, which are for devices equivalent to ones already marketed, fees wi...
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    Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022

    President Donald Trump late Friday signed a bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars and medical devices through 2022. Taking effect 1 October, the 86-page law (the text of which can be found here ) passed the House via voice vote in July and by a vote of 94-1 in the Senate earlier this month without the addition of any controversial amendments. The law ensures the ag...
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    Trump to Sign FDA User Fee Reauthorization Bill

    Ahead of its summer recess, the US Senate on Thursday followed its House counterparts and passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years. A spokesman for President Donald Trump told Focus , “The President will sign this bill, but we look forward to working with Congress to address further negotiations.” The Senate’s pas...
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    FDA Details Draft Goals for OTC Monograph User Fee Program

    After a series of discussions with industry and a public meeting in June 2016, the US Food and Drug Administration (FDA) last week released its draft goals letter for the proposed over-the-counter (OTC) monograph user fee program. The agency also announced on Tuesday that it will host a webinar to provide an overview of the proposed program to stakeholders on 23 August 2017. OTC Monograph User Fees Dubbed OMUFA, short for the yet-to-be introduced Over-the-Counter M...
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    Senate to Finish FDA User Fee Reauthorization Bill Ahead of Summer Recess

    Majority Leader Mitch McConnell (R-KY) said Tuesday that the Senate will follow its House counterparts and vote on the US Food and Drug Administration (FDA) user fee reauthorization bill before heading to recess at the end of next week. McConnell called to renew the user fee programs as they are “critical to speeding up the drug approval process, and that’s important for everyone frustrated by the time and cost of bringing lifesaving drugs to market. Without it, ...
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    Gottlieb: FDA Will Delay Sending Layoff Notices

    In an email to agency staff on Monday, FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after 30 September 2017, when the agency's current user fee agreements expire, if Congress has not passed legislation to reauthorize the agreements by then. Previously, FDA has said it would need to begin issuing layoff notices to thousands of employees that are funded by user fees if the agreements are not enacted by 1 August, as agencies are typically ...
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    Senate Appropriations Bill Maintains FDA Funding for 2018

    The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on Tuesday voted to advance its draft FY2018 appropriations bill, which includes $2.8 billion in discretionary funding for the US Food and Drug Administration (FDA). The full Appropriations Committee is scheduled to meet Thursday to mark up the bill before voting to advance it to the Senate for consideration. While the funding levels in the bill d...
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    Update: Gottlieb Lays Out Plans to Bolster FDA's Staff

    Editor's note: This article has been updated with the number of vacancies at CDER as of 8 July 2017. Looking to fill a "substantial" number of job vacancies, the US Food and Drug Administration (FDA) will soon pilot new hiring and recruitment procedures for its drugs and biologics programs. In a blog post Monday, FDA Commissioner Scott Gottlieb said the agency has struggled to keep pace with its staffing needs as it confronts increasingly complex and specialized produ...
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    White House Doubles Down on Call to Fund FDA Entirely With Industry Fees

    Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries. "The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs," the White House said in a statement . "In an era of renewed fiscal restraint,...