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  • Regulatory NewsRegulatory News

    FDA Issues New and Revised Guidance for Generic Drugs

    The US Food and Drug Administration (FDA) on Tuesday released a batch of 21 new and 16 revised draft guidances intended to help drugmakers conduct the studies needed to support the approval of certain generic drugs. Since formalizing its process for making such guidance available in 2010, FDA has published hundreds of product-specific bioequivalence guidances for various products. This is FDA's fourth recent release of new and revised bioequivalence guidance for generi...
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    House Committee Probes Restricted Distribution Systems Delaying Generics

    • 24 March 2017
    The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition. In his opening statement, Subcommittee on Health Care, Benefits and Administrative Rules Chairman Rep. Jim Jordan (R-OH) said that some drugmakers are manipulating the regulatory framework to block competitors from accessing the reference drugs they need to conduct bioequivalence testing t...
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    FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition

    The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis. In 2008, FDA approved Sirion Therapeutics' Durezol, a corticosteroid, to treat inflammation and pain associated with ocular surgery. Two years later, Alcon acquired the rights to Durezol from S...
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    Committee Recommends Adding UDIs to Insurance Claims Forms

    The group tasked with developing the standards for insurance claims forms on Wednesday recommended including unique device identifiers (UDI) on claims forms. Specifically, the Accredited Standards Committee X12 recommended that the device identifier portion of a UDI be included when high-risk devices are implanted or removed "due to safety concerns about premature failure." The recommendations are now undergoing a three-month consultation ending on 2 May 2017. Following...
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    When Can Drugmakers Cite Quality Standards From Foreign Compendia? FDA Explains

    An updated Manual of Policies and Procedures (MAPP) for the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lays out when drug sponsors and applicants can propose specifications for excipients, drug substances and drug products in their applications based on quality standards in the British Pharmacopoeia (BP), the European Pharmacopoeia (EP) or the Japanese Pharmacopoeia (JP). Updated from 2007 and 2014 versions, the MAPP says that such ci...
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    European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Maps International Regulatory Coordination Initiatives to Show Overlaps, Gaps The European Medicines Agency (EMA) has mapped cooperative regulatory initiatives to better understand how and where international peers are working together. EMA found there were a “myriad of initiatives but no strategic coordination,” prompting it to warn regulators are duplicating effo...
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    Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia . CFDA Posts Draft Medical Device Adverse Event Monitoring Guidance China’s Food and Drug Administration (CFDA) has posted draft guidance on post-marketing supervision of medical devices. The guidance sets out the role regional and national regulators, medical device manufacturers and adverse event monitoring technology institutions will play in tracking the safety of...
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    HHS Inspector General Calls on CMS to Incorporate UDIs Into Claims Forms

    In a letter to the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Andy Slavitt on Friday, Department of Health and Human Services (HHS) Inspector General Daniel Levinson calls on CMS to work with the Accredited Standards Committee (ASC) X12 to incorporate unique device identifiers (UDIs) for implantable devices into insurance claims forms. According to Levinson, doing so could help CMS keep track of the costs associated with recalled and defective me...
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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’s CBER to Forge Stronger Ties With WHO

    The US Food and Drug Administration (FDA) on Tuesday announced it’s forging a cooperative agreement with the World Health Organization (WHO) to support further regulatory systems strengthening, development of new norms and standards and research to advance global access to safe and effective biologics that meet international standards. FDA's Center for Biologics Evaluation and Research (CBER) anticipates providing up to $2 million in FY 2016 to support the project, as w...
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    European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs

    In the Official Journal of the European Union, the European Commission on Friday published a new list of the harmonized standards that manufacturers of medical devices, implantable devices and in vitro diagnostic devices can use to demonstrate their products comply with EU law. The standards were published as part of the implementation of the European Council’s Directive 93/42/EEC from 1993, which deals with medical devices and their regulation. Background ...
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    FDA Amends Regulations on General Biologic Standards for First Time Since 1977

    The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new manufacturing technology and testing capabilities. Issued directly as a final rule – because FDA says it believes the updates include “only noncontroversial amendments” and FDA anticipates no major objections from industry – the new regulations are part of FDA’s continuing effort to...