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    New Product-Specific Guidances Focus on Drugs Without Generic Competition

    The US Food and Drug Administration (FDA) on Tuesday issued 63 new and revised draft product-specific guidances detailing its expectations for companies looking to develop generic versions of those products.   Of the 63 guidances, 22 are new draft guidances and 41 are revised draft guidances. According to FDA Commissioner Scott Gottlieb, nearly 70% (43) of the guidances are for products that do not have any generic competition.   Some of the newly released draft gu...
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    FDA Sets Record for Number of Generic Drug Approvals Again

    The US Food and Drug Administration (FDA) has approved and tentatively approved more generic drugs in FY 2018 than any other year prior, the agency announced Thursday. The 971 total includes 781 final approvals and 190 tentative approvals, which compares with 937 total in FY 2017, which was the highest number of approvals since  2016 , which at the time set the previous record. “When I started as FDA commissioner, I made clear that one of my top priorities would be e...
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    Complex Generic Drugs: FDA Offers Two Draft Guidances

    The US Food and Drug Administration (FDA) on Tuesday unveiled one revised draft guidance and another new draft guidance to help advance the development of generic transdermal and topical delivery systems (TDS). Applied to a patient’s skin, TDS products are expected to deliver the correct medication dose consistently and for the expected length of time while adhering consistently and uniformly to the skin, even if exposed to water, humidity and movement. “Because of t...
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    Elemental Impurities Deadline Contributes to Spike in CRLs for Generic Drugmakers

    New generic drug applications are not winning a lot of approvals from the US Food and Drug Administration (FDA) so far in January 2018, and at least part of the reason for an increase in complete response letters (CRLs) is a new requirement from the US Pharmacopeia (USP). Lachman Consultants' Bob Pollock, a former official in FDA’s Office of Generic Drugs, first discussed the low number of abbreviated new drug application (ANDA) approvals in January – just four ap...
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    FDA Plots Policy Priorities for 2018

    The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency’s workforce. “Our work is taking place during an inflection point in both science and policy,” FDA Commissioner Scott Go...
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    FDA Denies Novo Nordisk Petition on Liraglutide Generics

    The US Food and Drug Administration (FDA) on Friday denied Novo Nordisk’s citizen petition that aimed to block generic versions of its blockbuster insulin Victoza (liraglutide) and two other products containing liraglutide. Novo argued that the Type 2 diabetes drugs containing liraglutide are large and complex molecules and that a manufacturing process that differs from its own might have unintended consequences. The company also argued that FDA has not issued guidan...
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    FDA Targets Multiple Review Cycles With New Draft Guidance, MAPP

    Fresh out of a record year for generic drug approvals, the US Food and Drug Administration (FDA) on Wednesday kicked off the new year by releasing new draft guidance and a new manual of policies and procedures (MAPP) with an eye toward decreasing the number of review cycles abbreviated new drug applications (ANDAs) undergo before approval. Multiple review cycles has been an outstanding challenge for the agency in years past, with less than 10% of ANDAs winning ap...
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    Ruling Against Novartis Could Have Wider Implications for Generic Drug Labels

    California's Supreme Court on Thursday ruled against Novartis in a decision that could have wider implications for whether brand-name or generic drugmakers should be held liable for warning consumers of risks in their drug labels. In a departure from other recent rulings, the highest California court found that a brand-name drug manufacturer's duty to warn consumers does extend to a generic, but only because federal regulations currently require generic drugs to carr...
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    Updated: Generic Drug Monthly Dashboard: FDA Adds New Metrics

    The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs. Whereas in previous years, the agency released monthly statistics on 12 different categories related to FDA’s review of abbreviated new drug applications (ANDAs), now the agency releases monthly data on 30 different categories. The new categories will shine a light on metrics where the generics industry has struggled in recent years, like...
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    Administering the Hatch-Waxman Amendments: Industry, Academics and Senator Discuss Balance

    The US Food and Drug Administration (FDA) has made it a priority to find a balance between encouraging innovative medical products and increasing access to lower-cost pharmaceuticals under the Hatch-Waxman Act 1984 . But when it comes to finding ways to speed the influx of generic drugs and stop frequently cited abuses, a host of voices from industry, academia and Congress are offering differing views. In July, FDA held a meeting to discuss certain situations in ...
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    FDA Updates Orange Book With Patent Submission Dates

    As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine the earliest date when they may be able to market new generics. FDA began collecting the patent submission date data in 2013, and the agency says there are about 4,000 patent records for which submission dates are available. The update is the result of a final rule fr...
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    FDA Expands Generic Drug Priority Reviews

    Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue. The progress comes as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday indicated that the agency will expand which abbreviated new drug applications (ANDA) will see priority reviews. "Earlier this year we made changes to how we pri...