• Regulatory NewsRegulatory News

    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...
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    FDA finalizes guidance on complex innovative trials designs

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance for sponsors on interacting with the agency on complex innovative trial designs (CID) for drugs and biologics.   The nine-page final guidance comes just over a year after the draft version was released for comment and two years after the agency launched its CID pilot program. (RELATED: FDA launches pilot program in support of complex trial designs for drugs and biologics , Regulatory Focus 2...
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    HMA Offers Recommendations on Complex Clinical Trials

    A subgroup of the EU’s Heads of Medicines Agencies (HMA) issued new recommendations Friday on conducting complex clinical trials.   The HMA’s Clinical Trials Facilitation Group (CTFG)—coordinated by the Danish Medicines Agency—identified eight key recommendations to establish a framework on the initiation and conduct of complex trials for the development of personalized medicine. They were prepared “in recognition of the fact that the development of personalized medici...
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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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    GAO to FDA: Publish Plans to Issue or Revise Guidance on Complex Generic Drugs

    The US Government Accountability Office (GAO) on Tuesday called on the US Food and Drug Administration (FDA) to announce plans to issue or revise guidance for complex generic drugs and FDA said it agrees with the recommendation and is working to do just that. The 50-page GAO report comes as FDA has sought to improve the way it reviews and approves these complex generic drugs, which can have a complex formulation, active ingredient, route of delivery, dosage form or ...
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    Gottlieb: More Guidance on Complex Generics Coming

    The US Food and Drug Administration’s (FDA) difficulties in approving generic versions of complex products were front and center in Commissioner Scott Gottlieb’s comments at FDA’s Generic Drug Science Day on Tuesday. Complex generic drugs – often declared complex because of their unique formulations (such as ophthalmic suspensions like with Allergan’s Restasis (cyclosporine), gels or others like Janssen’s chemotherapy Doxil ), active ingredients (including peptides...
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    FDA Targets Complex Generic Drugs With New Draft Guidance

    The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult. FDA Commissioner Scott Gottlieb spoke at the meeting on Monday morning, highlighting recent moves to establish a list of off-patent drugs that will receive expedited approval if an abbreviated new drug application (AND...
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    Complex Medicinal Products - the Other 'Biosimilar'

    This article discusses Non-Biological Complex Drugs (NBCDs) and how FDA and other regulatory agencies review and approve generic forms of these products. Introduction With all the attention recently focused on biosimilars, it might be easy to overlook another group of generics, the complex medicinal products. This group is generally referred to as Non-Biological Complex Drugs (NBCD) and also may be referred to as complex medicinal products. Like biosimilars, NBCDs may...
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    House Panel Calls on GAO to Study FDA’s Approval Pathway for Complex Generics

    Chairman of the House Committee on Energy & Commerce Fred Upton (R-MI), ranking member Frank Pallone (D-NJ) and other representatives on both sides of the aisle are calling on the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) approval pathway for generic drugs that have complex active pharmaceutical ingredients (APIs). The request for GAO action follows the introduction of HR 1576 in March, which also calls on GAO to study...
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    Does FDA Need New Authority to Regulate Complex Generic Drugs?

    New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority. Background The bill, the Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 , was introduced on 24 March 2015 by Rep. Michael Burgess (R-TX), a former physician and member of the House Energy a...