• Regulatory NewsRegulatory News

    FDA Warns Two Drugmakers for GMP Violations

    The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.   Vasco Rx   FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.   At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs pr...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese OTC Drugmaker, Florida Fertility Center

    The US Food and Drug Administration (FDA) last month sent warning letters to Chinese over-the-counter (OTC) drugmaker Hangzhou Guoguang Touring Commodity Co. and the University of Miami Reproductive and Fertility Center.   Hangzhou Guoguang   The warning letter comes after FDA placed Hangzhou Guoguang on import alert in October following an inspection of the company's Zhejiang facility over four days last April.   According to the warning letter, Hangzhou Guog...
  • Regulatory NewsRegulatory News

    Data Integrity Q&A: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics. The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to help drugmakers identify lapses and implement best practices to shore up any gaps in thei...
  • Regulatory NewsRegulatory News

    Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight. Background In recent years, FDA has worked to update its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths and new requirements brought on by the Drug Quality and Security Act (DQSA) of 201...
  • Regulatory NewsRegulatory News

    FDA Warns Fresenius Kabi API Manufacturing Plant

    The US Food and Drug Administration (FDA) last week released a warning letter sent to Fresenius Kabi's active pharmaceutical ingredient (API) manufacturing plant for liquid pharmaceutical products in Kalyani, India, for deficiencies that the company says will not impact product supplies. The warning letter, sent 18 December and following an eight-day inspection in April 2017, raises questions about Fresenius' failure to adequately address a sterility failure. FDA sa...
  • Feature ArticlesFeature Articles

    Regulatory Challenges for Direct-to-Patient Clinical Trials

    p> On-site clinical trials may present a number of participation obstacles for individuals living at distances from clinical trial sites or for patients with mobility problems. Direct-to-patient clinical trials can be an alternative. This article reviews applicable regulations and analyzes current strategies for conducting direct-to-patient clinical trials using technologies, such as mobile 'apps' and wearables to report data, as well as the potential for sending trial dr...
  • Regulatory NewsRegulatory News

    European Commission Consults on Revised GMPs for Sterile Drugs

    The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4 . The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times si...
  • Regulatory NewsRegulatory News

    3D Printing: FDA Finalizes Guidance for Medical Devices

    The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing. The guidance finalizes the draft version from May 2016 and largely keeps intact the recommendations and considerations laid out in the draft. FDA Commissioner Scott Gottlieb said Monday that the guidance "will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submis...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese Firm for Confusing API in OTC Drug

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last Monday to China-based Guangdong Zhanjiang Jimin Pharmaceutical Co. after finding that one of the over-the-counter drugs the firm made was labeled as containing the active pharmaceutical ingredient (API) hydrocortisone, but really the drug contained dexamethasone acetate. The company told FDA that the mix-up is the result of "a translation mistake," according to the warning letter...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Posts Draft Guidance on Postapproval Manufacturing Changes (24 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Draft Guidance on Postapproval Manufacturing Changes China Food and Drug Administration (CFDA) is seeking feedback on its guidance on postapproval manufacturing revisions. The draft texts propose three tiers of changes to production processes and detail the regulatory steps companies need to take in each circumstance. Echoing draft guidance posted by the US...
  • Regulatory NewsRegulatory News

    European Commission Adopts Two Acts on GMPs for Medicines

    Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use. One of the acts is an  implementing directive  that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization ( see Article 40 of the Community code Directive (2001/83/EC) ). The ...
  • Regulatory NewsRegulatory News

    Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans

    The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology. Background In contrast to batch manufacturing - where bulk materials are processed through multiple steps and subsequent batches must wait until the current batch is finished – continuous manufacturing allows companies to m...