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  • Regulatory NewsRegulatory News

    FDA Will Soon Need to Publish More Information About the Outside Standards it Uses

    The US government's Office of the Federal Register (OFR) has finalized a rule calling on the federal agencies, including the US Food and Drug Administration (FDA), to offer more information about third-party standards they require companies to comply with. Background If you're in the regulated healthcare products space—and in particular are involved with medical devices —you probably already know a thing or two about standards. There are of course standards FDA creates...
  • Regulatory NewsRegulatory News

    Anvisa Updates BA, BE Test Best Practices Certification

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies.  The practices are those that must be adopted by research centers in order to ensure their BA/BE studies—comparing pharma...
  • FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs

    The US Food and Drug Administration (FDA) has released 37 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence. Background Bioequivalence refers to the "absence of a significant difference" between the bioavailability—specifically the extent and rate of absorption—of two (supposed) pharmaceutical drug equivalents over the course of a period of time, at the sam...
  • Regulatory NewsRegulatory News

    Public Comment Period Opens on ISO 9001, Major Device Quality Standard

    The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation. Background The standard, which covers Quality Management Systems (QMS), undergoes  a revision process once every five years, and was last updated in 2008 (ISO 9001:2008). The ISO 9001 standard is used extensively throughout the medical...
  • Regulatory NewsRegulatory News

    Brazil Update: New Pharmacopeial Methods, Microbiology Testing Standards

    This content is provided by RegLink Associates . Read all of their Breaking News alerts on their website. Anvisa Proposes Alternative Pharmacopeial Methods Brazil’s national regulatory agency, Anvisa, is inviting comments on proposed alternative Pharmacopeial microbiological methods that can be used to replace those currently listed in the Brazilian Pharmacopoeia, with faster and better results.  The proposal complements the framework of documents t...
  • Regulatory NewsRegulatory News

    Australia’s TGA Issues Amended Bioequivalence Guidance

    Australia’s Therapeutic Goods Administration (TGA) has issued an amended bioequivalence guidance document applicable to all prescription medicines except for biologicals.  The guidance includes European Union guidelines that have been adopted by the TGA, such as the investigation of bioequivalence, the quality of modified release dosage forms, modified release oral and transdermal dosage forms, and the clinical investigation of the pharmacokinetics of therapeutic prot...
  • Regulatory NewsRegulatory News

    FDA Releases 33 New Medical Device Standards

    US medical device regulators have announced more than 30 new additions to their list of recognized device consensus standards. In a Federal Register announcement on 9 July 2014, the US Food and Drug Administration (FDA) announced its 36th update to its "List of Recognized Standards"—its fourth update to the list in 2014—containing dozens of modifications and 33 newly recognized standards. Those standards come to be recognized by FDA through a process known as "i...
  • FDA Re-Recognizes Three Radiology Consensus Standards

    The Center for Devices and Radiological Health (CDRH), the US Food and Drug Administration's (FDA) device regulatory body, has released another update-its 35th-to its list of recognized third-party standards. Background Standards for the proper manufacture and testing of products are often highly technical, time-consuming to produce and, above all else, expensive to create. Rather than create its own standards or duplicate the efforts of other groups, FDA often chooses ...
  • FDA Guidance: How to use Voluntary Consensus Standards Properly for Device Submissions

    A new draft guidance document issued by the US Food and Drug Administration (FDA) seeks to establish a framework for the use of voluntary consensus standards in medical device premarket submissions. Background FDA regularly establishes its own standards, such as through regulation or guidance documents, which product sponsors are expected to follow. However, it also regularly looks to standards set by outside bodies of experts, and adopts those standards in a process k...
  • FDA Formally Withdraws Approval for Second Generic Version of Popular Antidepressant

    This week the US Food and Drug Administration (FDA) formally-and quietly-withdrew a generic version of GlaxoSmithKline's Wellbutrin XL (bupropion) 300 mg following a determination that the drug was not bioequivalent to its originator. Background The withdrawal of the generic buproprion, an antidepressant marketed by Watson Pharmaceuticals, follows similar concerns raised about other generic versions of bupropion. In September 2012, FDA announced that it had asked Israe...
  • FDA Clears Way for Generics of 26 Popular Drugs

    The US Food and Drug Administration (FDA) has released 26 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence. Background Bioequivalence  refers to the "absence of a significant difference" between the bioavailability-specifically the extent and rate of absorption-of two (supposed) pharmaceutical drug equivalents over the course of a period of time, at ...
  • Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs

    The US Food and Drug Administration (FDA) has published a new draft guidance recommending various approaches when conducting bioequivalence (BE) and bioavailability (BA) studies in support of new and investigational drug applications. What Does FDA Mean by BA/BE? BA refers to the extent to which a drug is absorbed into the body and is thus available to act upon the drug's intended target, also known as the "site of action" (21 CFR 320.1[a]). For example, if a drug is in...