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  • Regulatory NewsRegulatory News

    FDA calls for stakeholders to join GDUFA talks

    The US Food and Drug Administration (FDA) this week called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Generic Drug User Fee Amendments (GDUFA III) program.   The call comes less than two months after the agency held its GDUFA III reauthorization kickoff meeting, during which industry stakeholders sought improvements to the generic...
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    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) on Friday released its latest batch of product-specific guidances, posting 19 new and 17 revised draft guidances, bringing the total number of product-specific guidances issued by the agency to 1,938.   The guidances , which FDA posts quarterly, are intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug...
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    FDA explains transfer of ownership policy for generics

    The US Food and Drug Administration (FDA) has issued a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.   The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of the drug application as well as the new owner.   To transf...
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    EC offers antitrust reassurances to generic drugmakers cooperating on shortages

    The European Commission on Wednesday reassured the generic drug association Medicines for Europe that member and nonmember companies can work together to battle shortages of critical hospital drugs to treat COVID-19 patients. The commission explains how generic firms may need to coordinate on stock management and distribution “so that not all undertakings focus on one or a few medicines, while others remain in under-production. Such coordination would be contrary to ant...
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    MHRA Offers No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies

    As another delay may push back Brexit to the end of January, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday published new guidance on comparator products (CPs) used in bioequivalence (BE), pharmacokinetic (PK) and therapeutic equivalence (TE) studies to support generic drug and other abridged marketing authorization applications following a no-deal Brexit. The guidance explains how it may be possible for an applicant to compare a proposed...
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    Another Record Year for Generic Drug Approvals but Questions on Competition Remain

    For each of the last five years, the US Food and Drug Administration (FDA) has set generic drug approval records, but questions have lingered on whether these high approval numbers are translating into competition. FY 2019 figures show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals), which breaks FDA’s previous all-time record of 971 full and tentative approvals for FY 2018 . And although the abbreviated new drug application (...
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    FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development

    The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products. When finalized, the guidance documents will represent the current thinking of FDA on, among other things, the product-specific design of bioequivalence studies to support abbreviated new drug applications. Among th...
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    Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger

    Another year, another record number of generic drug approvals and tentative approvals for the US Food and Drug Administration (FDA). This has been the story at FDA from FY 2016 to FY 2017 to FY 2018 and now to FY 2019 , with two months to spare. But questions remain on whether these approvals are actually translating into greater competition and lower costs for patients. A report from Pew earlier this year found that the increase in approved generic drugs fr...
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    FDA Releases New Data to Help Generic Drug Competitors

    Generic drug applicants will now have more information from the US Food and Drug Administration (FDA) when deciding whether to file a generic drug application, which could potentially increase the odds of earlier approvals, the agency said on Tuesday. Previously, FDA’s Paragraph IV Patent Certifications List included only the name of the drug (along with the dosage form and strength) and the date on which the first substantially complete generic drug application that ...
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    Industry Seeks Clarity on CGT Draft Guidance

    Pfizer, Perrigo, Teva, Apotex and the Association of Accessible Medicines all sought further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the competitive generic therapy (CGT) designation and CGT exclusivity. The CGT designation is meant to be an incentive for industry to develop generics for drugs that have only one competitor. To date, FDA has granted more than 100 CGT designation requests, and in 2018, between August and Decembe...
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    Health Canada Opens Generic Drug Guidances for Consultation

    Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.   Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.   “The draft guidance documents have been releas...
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    Trump’s 2020 Budget Seeks FDA Tweaks to Increase Generic Competition

    With Democrats controlling the House, the specifics of President Donald Trump’s Fiscal 2020 budget, released on Monday, may not matter much, but it does feature new attempts to alter US Food and Drug Administration (FDA) processes in order to increase generic drug competition. Similarly to last year’s budget , the 2020 budget looks to save more than $1 billion in Medicare and Medicaid funds by stopping some generic drug applicants, who file first and win tentative appr...