• Feature ArticlesFeature Articles

    Integrating master files in the NDI notification process to facilitate innovation in dietary supplements

    This article discusses the application of master files to the new dietary ingredient notification process to protect intellectual property of ingredient manufacturers and incentivize submission of NDI notifications. The author describes an NDI master file model, based on the US drug master file, as a proposal for consideration by the US Food and Drug Administration.   Introduction Innovation grows industries, and it is no different for the dietary supplement industry...
  • Regulatory NewsRegulatory News

    NDI Guidance: The Waiting Game

    This article discusses FDA's publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) and the implications regarding the lack of finalization in the year following its publication. The authors make suggestions regarding what companies may begin doing prior to and in anticipation of eventual finalization. Introduction Regarding how dietary supplements should be regulate...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Releases New Guidance on Device Trial Inspections (24 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Releases Clutch of Draft Medical Device Clinical Trial Texts China Food and Drug Administration (CFDA) has released a handful of draft documents about clinical trials of medical devices. The documents, which detail the process for on-site inspections and the products that are exempt from studies, continue the ongoing overhaul of the regulation of medical devices in Chi...
  • Regulatory NewsRegulatory News

    FDA Finds Prozac in USPlabs Supplement, but Company Claims it’s a Counterfeit

    A dietary supplement firm long on the US Food and Drug Administration's (FDA) enforcement radar is again in the agency's sights after regulators claim they found fluoxetine, the active ingredient in Prozac, in one of the company's former fitness products. Background The company, USPlabs, has been linked to several FDA enforcement actions in recent years. In December 2012, FDA sent the company a Warning Letter regarding three of its products: Jack3D, Super Cissus an...
  • Spain Launches new Registry of API Manufacturers, Distributors, Importers

    The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, import and distribution of pharmaceutical active ingredients in Spain. The Unified Public Business Registry of Active Substance Businesses (RUESA) is part of the transposition of Directive 2011/62/EU , which addresses counterfeit drugs in the European Union and includes additional controls for active ingredients. The aim of the RUESA is to s...
  • ICH Working Group Calls for Revisions to Q7 Guideline

    The International Conference on Harmonisation (ICH) has published a new concept paper regarding the standardized regulation of good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), the first step in reforming the organization's Quality 7 (Q7) Guideline. The paper, endorsed by ICH's Steering Committee in October 2012 and released in November 2012, refers to the widely-used Q7 GMP Guidance for APIs , released in November 2000. The document, I...