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    Industry pushes FDA for tailored complex generics post-approval changes guidance

    The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval changes for non-complex generics as current versions are outdated, according to representatives of the generics industry.   The remarks were made during a panel on post-approval changes for complex generics on 9 November at the Association for Accessible Medicines’ (AAM) GRx+Biosim held a conference in Bethesda, ...
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    FDA sees room for growth for complex generics

    The complex generic market needs to “achieve parity” with the innovator market, as the number of approvals is lagging the innovator sector and has not achieved its full market potential, said Robert Lionberger, director of the US Food and Drug Administration’s (FDA) Office of Research and Standards in the Office of Generic Drugs (OGD).   Lionberger made the remarks at the Association for Accessible Medicines’ (AAM) GRx+Biosim conference in Bethesda, MD last week.   ...
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    FDA announces website for complex generics

    The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development.   “Since these products are generally harder to develop, fewer exist, resulting in less market competition. This means that complex generics may be more expensive and less accessible to the patients who need them,” said the FDA announcement. “Complex generics are a key component of FDA’s Drug Competit...
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    FDA seeks to streamline inactive ingredient database with industry input

    The US Food and Drug Administration (FDA) wants to know how it should prioritize maximum daily exposure (MDE) information and whether it should remove dosage form information from its inactive ingredient database (IID). The move is part of the agency’s commitment to industry to streamline the drug database.   On 21 March the FDA published a notice asking drug makers and other stakeholders what it should do to streamline the IID. As part of the generic drug user fee a...
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    FDA announces FY 2022 GDUFA science and research priorities

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022 to spur the development of complex generic drugs. The priorities were prompted by public feedback the agency received at a public workshop earlier this year.   The agency also announced the availability of fellowships and funding for research activities that are aligned with these priorities.   The workshop was held i...
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    New reports address generics pricing, innovation in the EU

    A European generics trade association is calling for relaxation of “extreme cost containment policies” against generic medicines, asserting that such measures are counterproductive and may endanger the supply chain through consolidation of production and withdrawal or products from the market.   “The European Commission has collected a growing body of evidence showing that extreme cost containment policies applied to generic medicines are counterproductive, driving ind...
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    GDUFA III fiscal details emerge

    The generics industry can expect the US Food and Drug Administration (FDA) to take a more flexible approach to resource capacity planning and continue a commitment to financial transparency, according to fiscal experts from the agency who spoke at an FDA meeting earlier this week.   Although much of the framework for the third reauthorization of the Generic Drug User Fee Amendments (GDUFA III) program could be gleaned from the commitment letter released by the US Foo...
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    FDA releases 4 dozen new and updated PSGs

    Four dozen new or updated product-specific guidances (PSGs) were released Monday by the US Food and Drug Administration (FDA). Along with the new and updated guidances, FDA also issued a newly developed infographic that provides a snapshot of the overall PSG program.   “PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, thereby helping to streamline generic drug produ...
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    FDA shows jump in competitive generic approvals

    The US Food and Drug Administration (FDA) approved a steadily increasing number of competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) in FY 2021 while the number of priority generic approvals leveled off, according to agency’s quarterly data on reviews and approvals of priority and competitive generics.   FDA approved 29 priority ANDAs in FY 2021, one more than the 28 approved in  FY 2020 . There was an increase of about 8% in the number of ...
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    FDA refreshes bioequivalence guidance for generic drugs

    Generic drug makers received a refreshed draft guidance from the US Food and Drug Administration on Friday; the guidance updates some recommendations on the conduct of bioequivalence (BE) studies that have pharmacokinetic endpoints.   In announcing the updated draft guidance’s availability, FDA said that the document is meant to "clarify the agency’s recommendations regarding BE information submitted in an [abbreviated new drug application] submission, provide assistan...
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    AAM: Medicare Part D plans slow to adopt generics

    Medicare Part D plans are slow to adopt generic medications for their beneficiaries, according to a recent report released by the Association for Accessible Medicines (AAM).   For the 2021 plan year, Medicare Part D formularies covered 21% of approved first generic medications from the previous year compared with the 66% covered by commercial formulary plans, the report stated. But this is part of a years-long trend, according to AAM. Not only do Medicare Part D plans ...
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    FDA’s OGD hears ways to accelerate complex generic development

    Pharmaceutical industry officials speaking at a Wednesday workshop on complex generics suggested that the US Food and Drug Administration (FDA) create alternative pathways for assessing bioequivalence for some of these products and provide more guidance on assessing the bioequivalence of metered-dose inhalers.   A series of industry officials spoke at a 23 June public workshop on ways the agency could accelerate the development of complex generics. The agency is requir...