• Regulatory NewsRegulatory News

    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
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    Senate Committee Advances OTC Monograph Reform Bill

    The Senate Health, Education, Labor and Pensions Committee on Thursday advanced a bill by voice vote that would reform the way over-the-counter (OTC) drugs are brought to market by creating a user fee system like the ones used for prescription drugs and devices. The bill, introduced by Sens. Johnny Isakson (R-GA), who’s resigning from the Senate at the end of the year, and Bob Casey (D-PA), aims to speed up the antiquated approval process for OTC drugs and would create ...
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    New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance on the US Pharmacopoeial Convention Pending Monograph Process (USP-PMP), outlining how sponsors can revise or create new monographs so they are harmonized with a new product’s FDA-approved quality and labeling requirements.   Background   New and generic drug applicants and drug master file holders must ensure that a drug product or substance complies with applicable standards in the US...
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    Public Citizen Sues FDA Over OTC Drug Risks

    Nonprofit Public Citizen on Thursday sued the US Food and Drug Administration (FDA) alleging that the agency has failed to act on safety issues related to the over-the-counter (OTC) drug benzocaine. The lawsuit, filed on the grounds that FDA is in violation of the Administrative Procedures Act for "withholding or unreasonably delaying action" on a citizen petition filed by Public Citizen in 2014 that calls on the agency to add a warning that benzocaine can cause ...
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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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    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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    FDA Considers New User Fee Program for OTC Drugs

    The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs. User fee programs (such as PDUFA , GDUFA , BsUFA and MDUFA , all of which are now being re-negotiated for 2017) are the life blood of FDA and provide much-needed financial resources from industry, in addition to Congressional appropriations, that support the timely and efficient review of...
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    FDA Finalizes New Approach on Naming Drugs Containing Salt Drug Substances

    The US Food and Drug Administration (FDA) has finalized a new policy detailing how manufacturers of drug products containing salts should name their products. Background The guidance document, Naming of Drug Products Containing Salt Drug Substances , was first released in draft form in December 2013 following the May 2013 implementation of the US Pharmacopoeia's (USP) monograph on naming new drug products, Monograph Naming Policy for Salt Drug Substances in Drug P...
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    Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

    Senate legislators have released a new iteration of the Sunscreen Innovation Act , a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs. Background As explained in our article on the House version of the Sunscreen Innovation Act , the bill has long been focused on the Time and Extent (TEA) application ...
  • Health Canada Overhauls Product Monograph Guidance

    Health Canada issued revised product monograph  guidance  on 4 April 2014 that sets forth new design and format requirements, and also includes a new section on preparing patient information. According to Health Canada, the changes are intended to emphasize clinical relevance, make information easier to retrieve and provide format and information consistency across different drugs and drug classes. The revisions also include specific guidance for the followi...
  • Australia Proposing 12 Month Trial Period for OTC Monograph Process

    Australia's Therapeutic Goods Administration (TGA) opened a consultation on 18 June 2013 on the implementation of a 12-month trial period of an Over-the-Counter (OTC) New Product N2 application (or Monograph application) route to market. N2 applications will involve significantly reduced requirements for data assessment and consequently shorter evaluation timelines. Instead of providing full supporting data with the application, sponsors will only need to confirm that...
  • USP Sets Date for Overhaul of Monograph Naming Policy

    • 20 November 2012
    The US Pharmacopeia (USP) has released a new policy it says will bring both clarity and consistency to the naming of new drug products based on their clinically active components. In a 19 November 2012 press release, USP said the new naming policy will come into effect on 1 May 2013, and will apply prospectively-not retroactively-to all drug product and compounded preparation monographs appearing in its compendia. The new policy, Monograph Naming Policy for Salt Dru...