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  • Regulatory NewsRegulatory News

    FDA Consults on ICH Biopharmaceutics Classification System-Based Biowaivers Guideline

    The US Food and Drug Administration (FDA) on Thursday released its version of the International Council for Harmonisation (ICH) biopharmaceutics classification system (BCS) -based biowaivers guideline for consultation.   The draft guideline, which reached Step 2b of the ICH process in June, is currently under consultation by the group’s regulatory members and is expected to be adopted in May 2019. FDA is asking interested parties to submit their comments on the guideli...
  • Regulatory NewsRegulatory News

    FDA Tweaks List of Recognized Consensus Standards for Devices

    A total of about 90 consensus standards used for device premarket reviews and other device regulatory requirements will undergo certain modifications set forth Friday in a notice from the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).   The 14-page notice “will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices,” CDRH said. It includes a list of the modif...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Waivers for Bioavailability and Bioequivalence Studies

    The US Food and Drug Administration (FDA) on Friday finalized guidance for sponsors who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirements for immediate release (IR) solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS). The guidance, finalized from a 2015 draft, explains what is necessary for sponsors of investigational new drugs (INDs) and applicants of new drug ...
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    Use of Standards at CBER: New Draft Guidance

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Monday released draft guidance offering recommendations on the use of standards in product development and the use of such standards in CBER’s managed review process. The draft describes how standards are developed, the benefits of using standards and CBER’s policy on accepting standards used in regulatory submissions. Questions and answers contained within the draf...
  • Feature ArticlesFeature Articles

    A New Regulatory Paradigm for Medical Devices in India

    This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes. Introduction Medical devices are a multi-billion-dollar global industry with continuous growth opportunities due to advancements in technology and new innovations. However, innovations and new advancements do not always reach patients due to a lack of clarity related to the approval p...
  • Regulatory NewsRegulatory News

    ISO: Identification of Medicinal Products Standards Revised

    The International Organization for Standardization (ISO) is revising a series of standards known as Identification of Medicinal Products (IDMP) standards as part of an effort to simplify the exchange of medicinal product information. "When regulators adopt IDMP, their capacity to interoperate with each other makes for safer patient care; this is, for example, a huge benefit for adverse-event reporting and for documenting medication in patient records," Christian Hay...
  • Regulatory NewsRegulatory News

    UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments

    Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopeial standards for biologics, according to a report issued Monday. In general, MHRA says the responses supported the value of standardization, and found that areas where standards could add value included providing guidance and ensuring consistency for product characterizat...
  • Feature ArticlesFeature Articles

    Bioequivalence Studies of Solid Oral Dosage Forms Overview

    The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US. Introduction 'Generic' drugs offer a significant cost saving and are ...
  • Regulatory NewsRegulatory News

    FDA Finalizes 46 Bioequivalence Guidances

    In its continued push to support the development of generic drugs, the US Food and Drug Administration (FDA) on Friday finalized 46 product-specific bioequivalence guidances. The guidances, which lay out FDA's expectations for the studies that should be done to demonstrate that a generic drug is bioequivalent to its reference product, give specific recommendations for what analytes to measure, what dissolution test methods and sampling times Some of the guidances also s...
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    CDRH Clarifies Process for Consensus Standard Recognition Requests

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices, as required by the 21st Century Cures Act . Medical device makers often rely on consensus standards in the development and testing of their products, and FDA allows device makers to submit a declaration of conformity to show that the...
  • Regulatory NewsRegulatory News

    FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances

    • 13 July 2017
    The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies. FDA is announcing the availability of a new draft product-specific guidance for industry for drug products containing the following active ingredients: FDA is seeking feedback on the drafts before it begins work on the final versions of product-specific guidance. FDA  last issued  a batch of s...
  • Regulatory NewsRegulatory News

    FDA Seeks Input on Device Accreditation Pilot

    The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions. As part of the agency's negotiations with industry for reauthorizing the Medical Device User Fee Amendments (MDUFA) , FDA agreed to establish a program for accrediting test labs that evalu...