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    FDA Adds 34 New and 33 Revised Bioequivalence Study Recommendations for Generic Drug Developers

    • 04 October 2016
    The US Food and Drug Administration (FDA) on Tuesday published 67 generic drug-specific recommendations (34 new and 33 revised) describing the agency’s expectations for developing generics that are therapeutically equivalent to reference-listed drugs (RLDs). The guidance is intended to help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval. This is FDA’s third r...
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    FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

    The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies. The 142-page proposed rule outlines what’s referred to as a “GLP Quality System,” which will involve additional management responsibilities and standard operating procedures (SOPs), as well as a more nuanced approach for multi-site ...
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    FDA Issues New Guidance on Osteoporosis Drug Development

    The US Food and Drug Administration (FDA) on Monday issued new draft guidance calling for drugmakers to conduct long-term nonclinical bone quality studies for osteoporosis treatments. According to FDA, such studies are necessary for osteoporosis drugs to determine whether the drugs result in poorer bone quality when taken for long periods of time. Additionally, FDA says these studies should be nonclinical, as "there are no validated and reliable methods for the noninvasi...
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    FDA Draft Guidance to Assist CMS With IDE Coverage Decisions

    The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS). While an agreement has been in place between the two agencies for more than two decades, FDA says it has run into issues with some devices not easily fittin...
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    FDA Finalizes Guidance on Postmarket Device Surveillance

    The US Food and Drug Administration (FDA) on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices. The guidance comes as the Government Accountability Office (GAO) said last October that 90% of the postmarket surveillance studies FDA ordered over the past seven years were categorized as inactive, though some...
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    On Eliminating Two-Year Rat Carcinogenicity Studies for Pharma: ICH Seeks More Data

    The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) will continue to study for two more years whether guidance can be revised on certain situations when sponsors will not have to conduct and submit a two-year rat carcinogenicity study for a developing drug. In order to test the feasibility of eliminating such studies in some cases, which would be part of revisions to ICH’s S1 Guideline , ICH began collecting vol...
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    Transparency: What FDA Drug, Device Regulations are Coming Later in 2016

    As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules. By 31 March, according to the TRACK database, the agency expects to release four final rules and three propose...
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    FDA Shares Views on Juvenile Animal Studies for Oncology Drugs

    In a recently published article, officials from the US Food and Drug Administration (FDA) say that studies comparing the effects of drugs in juvenile animal populations against their effects in adult animals are generally not useful in guiding pediatric clinical development, especially if such studies delay the launch of a clinical trial. The authors of the article, John Leighton, Haleh Saber, Gregory Reaman and Richard Pazdur, of FDA's Office of Hematology and Oncology ...
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    New Senate Bill Would Change the Way FDA Regulates Devices

    A new Senate bill introduced this week would, among other things, allow the US Food and Drug Administration (FDA) to no longer require premarket submissions for some low-risk Class I and II medical devices. The bill, which is sponsored by Sens. Amy Klobuchar (D-MN) and Pat Roberts (R-KS), and supported by industry group AdvaMed, would also: Require FDA to address within two months any changes proposed to an appropriate standard established by a nationally or internati...
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    Woodcock: Drug Safety Surveillance System Ready for Full Operation

    The US Food and Drug Administration's (FDA) Sentinel database tracking medical product safety events is now an "integral part of routine safety surveillance," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA said at the 8 th Annual Sentinel Initiative Public Workshop in Washington, DC, Wednesday. "We can, as of today, officially drop 'Mini' from the Sentinel title," she said, noting the progress made since the agency began transition...
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    FDA Offers New Bioequivalence Study Guidance for 31 Generic Drug Ingredients

    To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs. The myriad new draft guidance documents focus on what types of bioequivalence (BE) studies may need to be conduct...
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    Device Industry Calls for Clarifications to Draft Animal Studies Guidance

    The Advanced Medical Technology Association (AdvaMed) is calling on the US Food and Drug Administration (FDA) to clarify aspects of a recent draft guidance intended to set expectations for animal studies for medical devices. Draft Guidance FDA released the draft guidance, General Considerations for Animal Studies , for public comment in October 2015. The guidance is intended to assist industry in designing, conducting and reporting data from animal studies used to de...