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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Promotional Drug Labeling and Ads

    The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs. FDA said it received one comment on the revised draft guidance, and in addition to a title change and editorial changes made primarily for clarification, the guidance has been revised to clarify certain concepts discussed in the revised dr...
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    HHS Secretary Nominee Azar: Top Priority is Drug Prices

    The Senate Health, Education, Labor and Pensions Committee hearing on Wednesday grilled President Donald Trump's HHS secretary nominee and former Eli Lilly executive Alex Azar on drug prices, and he vowed that the issue would be his top priority. Sens. Rand Paul (R-KY), Elizabeth Warren (D-MA), Tammy Baldwin (D-WI), Maggie Hassan (D-NH) and others questioned Azar on how he would oversee an industry that he used to work for. "I don't have pharma's policy agenda," A...
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    IGDRP Offers Guidance for Quality Assessors on Drug Substances

    The International Generic Drug Regulators Programme (IGDRP) on Tuesday released guidance finalized in June to help regulatory agencies’ quality assessors review technical information on active substances. Initially drafted by regulators from Australia, Canada, Singapore and Switzerland, the document provides assistance to quality assessors in reviewing the technical information contained in the Quality Module (Module 3) of Active Substance Master Files (ASMFs)/Drug...
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    FDA Issues Delayed DSCSA Grandfathering Guidance

    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA). While the guidance comes two years after the deadline set by the DSCSA and on the same day that requirements for manufacturers to begin affixing or imprinting product identifiers on packages and homogenous cases ...
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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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    Stakeholders Weigh FDA Proposal to Limit Risk Info in DTC Advertisements

    Industry and pharmacy groups generally support the US Food and Drug Administration's (FDA) proposal to limit the amount of risk information presented in pharmaceutical direct-to-consumer (DTC) advertisements, though others have criticized the plan and research backing it as flawed. Background In August, FDA proposed a new approach to presenting risk information in DTC television and radio ads that would allow drugmakers to limit the amount of risks presented. Cu...
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    Updated: House Passes GOP Tax Overhaul With Orphan Drug Tax Credit Repeal Included

    The US House of Representatives on Thursday passed a bill to reform the US tax code by a vote of 227 to 205, with all Democrats voting against it and all but 13 Republicans voting for it. The House-passed bill includes several provisions that would be attractive to the biopharma industry, though industry groups BIO and the National Organization of Rare Disorders took issue with a provision to repeal the orphan drug tax credit, which amounts to half of all qualified ...
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    Drug Labels: Experts Note Importance of Faster Updates

    The topic of cancer drug labels and how they can be updated more quickly, as well as how the labeling system needs to be reformed was front and center at several panels at the Friends of Cancer Research's annual meeting in Washington, D.C. on Wednesday. Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), noted her agency has been working on the issue of label updates for a number of years, particul...
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    Senate Tax Plan Seeks to Reform, Rather Than Repeal, Orphan Drug Tax Credit

    The Senate’s tax plan, running counter to the House’s call to eliminate the orphan drug tax credit for research on drugs to treat rare diseases, seeks to modify the credit instead. The proposal would limit what level of expenses will qualify and limit qualified clinical expenses if they are related to the use of a drug which has previously been approved for diseases or conditions affecting more than 200,000 persons in the US. The tax credit is part of a law from...
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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...
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    Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition. The comment followed Gottlieb's discussion of the ways in which brand-name drug companies can use Risk Evaluation and Mitigation Strategies (REMS) or other tactics to prevent generic companies from purchasing drug product to run bioequivalence or bioavailability studies necessary for approval. Federal...