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    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    New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance on the US Pharmacopoeial Convention Pending Monograph Process (USP-PMP), outlining how sponsors can revise or create new monographs so they are harmonized with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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    Pfizer Proposes to Make Viagra Available in the UK Without a Prescription

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a Pfizer proposal calling to make the popular erectile dysfunction drug sildenafil (more commonly known as Viagra) available without a prescription at UK pharmacies. MHRA said it considers that “direct risks can be minimised to an acceptable level for Pharmacy supply of sildenafil 50mg tablets.” Other ways to minimize those risks include Pfizer’s proposal that the drug only be made availa...
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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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    Taiwan Regulators in Push to Switch More Drugs to OTC Status

    The Taiwan Food and Drug Administration (TFDA) announced this month that it will be reclassifying 13 prescription drugs to be available over the counter (OTC), the Taipei Times reports. The move is part of a larger push in Taiwan to improve access to basic medicines and reduce healthcare spending. The regulator is planning for the reclassified products to be available for OTC sales in June 2015. Self-Medication TFDA said it is looking to reclassify as many pres...
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    UK's MHRA Puts New Restrictions on Popular Painkiller

    A widely used over-the-counter painkiller has been reclassified as a prescription-only medicine (POM) by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). In a press release on 14 January 2015, MHRA announced that patients will now need a prescription to purchase diclofenac oral tablets. The agency cited concerns over “increased risk of serious cardiac side effects in some patients,” which is worsened by long-term or high-dose use. The decision to re...
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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 ...