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  • Regulatory NewsRegulatory News

    EU Takes Another Step Towards Adopting SPC Waiver Proposal

    The European Union’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) is one step closer to adoption after EU ambassadors endorsed a compromise reached on 14 February with the European Parliament during a meeting of the Committee of the Permanent Representatives (Coreper) on Wednesday.   Now that the draft regulation has been agreed to, it will undergo a legal and linguistic review before being sent to the European Parliament and C...
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    FDA Names New Office of Generic Drugs Director

    In an email to staff on Tuesday, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced that Sally Choe will take over for Kathleen Uhl as Director of the Office of Generic Drugs (OGD) upon Uhl’s retirement at the end of the month after serving more than 20 years at the agency.   “With more than 18 years of experience in global drug development, Sally is an accomplished leader in both governmen...
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    New Formulations Can Delay Generic Drug Entry, Study Finds

    A new study in the Journal of Managed Care & Specialty Pharmacy finds that the introduction of new formulations of drugs often delays the introduction of generic competitors by two or more years.   The study, authored by researchers at Harvard Medical School and Brigham and Women's Hospital's Program on Regulation, Therapeutics and Law (PORTAL), tracked 17 small molecule drugs approved in 2002 over the course of 15 years to see how the introduction of new formulation...
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    European Commission Consults on Orphan Drug Applications

    The European Commission on Tuesday launched a targeted consultation to provide input on a revision of its guideline on the content and format of applications for orphan drug designation, as well as the transfer of designations between sponsors.   "The comments received will be taken into account by the European Commission in the finalization of the guideline on the format and content of application for designation as orphan medicinal products and on the transfer of des...
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    FDA's Record Year: A Look at 2018 New Drug Approvals

    The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...
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    FDA Withdraws Proposed Rule on Generic Label Changes

    The US Food and Drug Administration (FDA) on Thursday withdrew a proposed rule on label changes for generic drugs after concerns were raised by commenters and FDA resources were considered. The proposed rule from 2013 would have allowed abbreviated new drug application (ANDA) holders for generic drugs to independently update and promptly distribute revised product labeling to reflect newly acquired safety-related information, even if the revised labeling may temporarily...
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    Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal

    The European Parliament’s International Trade Committee (INTA) on Monday voted to adopt a draft opinion supporting changes to an amendment that would allow for manufacturing waivers to supplementary protection certificates (SPCs).   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse be...
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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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    Complex Generic Drugs: FDA Offers Two Draft Guidances

    The US Food and Drug Administration (FDA) on Tuesday unveiled one revised draft guidance and another new draft guidance to help advance the development of generic transdermal and topical delivery systems (TDS). Applied to a patient’s skin, TDS products are expected to deliver the correct medication dose consistently and for the expected length of time while adhering consistently and uniformly to the skin, even if exposed to water, humidity and movement. “Because of t...
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    FDA Warns of Dosing Errors With Compounded Injectables

    The US Food and Drug Administration (FDA) last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may lead to dangerous dosing errors.   "Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently," FDA writes.   For small volume parenteral drugs a...
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    Elemental Impurities Deadline Contributes to Spike in CRLs for Generic Drugmakers

    New generic drug applications are not winning a lot of approvals from the US Food and Drug Administration (FDA) so far in January 2018, and at least part of the reason for an increase in complete response letters (CRLs) is a new requirement from the US Pharmacopeia (USP). Lachman Consultants' Bob Pollock, a former official in FDA’s Office of Generic Drugs, first discussed the low number of abbreviated new drug application (ANDA) approvals in January – just four ap...
  • European Regulatory Roundup: France Targets 80% Biosimilar Penetration by 2022 (4 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news . Ireland Offers to Waive Certain Fees to Ease Impact of Brexit Ireland is offering to waive the fee for certain Brexit-triggered regulatory requests. The offer will allow companies to change their reference member state (RMS) from the United Kingdom to Ireland for free. Officials from the Health Products Regulatory Authority (HPRA) of Ireland made the offer in guides on ...