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  • Regulatory NewsRegulatory News

    Drugmakers Can Now Submit Pre-Assigned Number Requests via CDER’s Portal

    • 19 August 2019
    • By  
    Beginning Monday, prospective applicants can submit pre-assigned number requests for four additional application types: new drug application (NDA), investigational new drug (IND) application, biologic license application (BLA) and drug master file (DMF), via the Center for Drug Evaluation and Research (CDER)’s NextGen Portal.   The pre-assigned number requests were previously made via email. But now the firms submitting such applications can use the portal, which is a ...
  • Regulatory NewsRegulatory News

    What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains

    The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...
  • Regulatory NewsRegulatory News

    FDA Delays eCTD Requirements for Master Files

    The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised guidance released Friday, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to be submitted in eCTD format until 5 May 2018. Other documents, such as new drug applications (NDAs), abbreviated new drug applications (ANDAs) and...
  • Feature ArticlesFeature Articles

    Worksharing in the Evaluation of Active Substances

    This article describes ongoing procedures and initiatives for 'worksharing' in the evaluation of active substance dossiers by regulatory authorities around the world. Introduction An Active Substance or Drug Master File (ASMF/DMF) can be used to describe the chemistry, manufacture and controls for an active substance. It is typically divided into an applicant's or open part and a restricted or closed part. The applicant's part is provided to the Marketing Authorizatio...
  • Regulatory NewsRegulatory News

    FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

    Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...
  • US Throws Out 1995 Standard for Generics Stability Testing, Adopts ICH Standards for NDAs Instead

    The US Food and Drug Administration (FDA) has released a new guidance for industry that pertains to stability testing recommendations for generic drug products submitted under 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) as an abbreviated new drug application (ANDA) or a drug master file (DMF). The June 2013 guidance document, ANDAs: Stability Testing of Drug Substances and Products , explains that, "Over the past few years, the Office of Gener...
  • FDA Releases Generic Drug User Fee Schedule, Backlog Fees

    The US Food and Drug Administration (FDA) has released the last of its user fees for pharmaceutical products, disclosing the user fees payable to the agency for the submission of abbreviated new drug applications (ANDAs), prior approval supplements (PASs), drug master files (DMFs) and for the clearance of a backlog of ANDA submissions . Since the signing of the FDA Safety and Innovation Act by President Obama in July 2012, FDA has been steadily releasing guidance do...
  • New Draft Guidance Aims to Ease Process of Referencing Drug Master Files

    The US Food and Drug Administration (FDA) has released new draft guidance on how it assesses the completeness of drug master files submitted to it under generic drug applications, aiming to streamline the process for all parties involved. Drug Master Files (DMFs) are submitted to FDA, and contain confidential information regarding a specific company's processes, establishments or manufacturing capabilities. They are an optional submission, and may be used by FDA to mor...
  • Feature ArticlesFeature Articles

    Comparing Drug Master File Procedures in Highly Regulated Markets

    Drug Master Files (DMFs) are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug's identity, strength, purity and quality. The DMF procedure exists all over the world, from highly regulated markets (HRMs) through nearly regulated markets (NRMs). The HRMs, such as the US, EU, Japan, Can...
  • FDA Releases New Veterinary CMC Guidance

    The US Food and Drug Administration (FDA) is releasing new guidance for industry for chemistry, manufacturing and controls (CMC) information relating to fermentation-derived products, including intermediates, drug substances and related drug products for veterinary medicinal use. The guidance "provides recommendations on what documentation to submit to support the [CMC] information" for veterinary products to the Center for Veterinary Medicine (CVM). "This information i...