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  • Regulatory NewsRegulatory News

    Researchers Pilot Ingestible Electronic Sensor to Monitor Microbiome

    Australian researchers have conducted a human trial that they say illustrated the potential role for electronic-based gas-sensing capsules in understanding aspects of the intestine and its microbiota in health, according to an article published online on Monday in Nature Electronics . The ingestible sensors used in the trial can sense oxygen, hydrogen and carbon dioxide by using a combination of thermal conductivity and semiconducting sensors, the researchers said,...
  • Regulatory NewsRegulatory News

    FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

    The US Food and Drug Administration (FDA) on Tuesday issued two draft guidances aimed at updating its recommendations for in vitro diagnostics (IVDs) seeking a waiver from requirements under the Clinical Laboratories Improvement Amendments (CLIA) in line with provisions of the 21st Century Cures Act and the recently reauthorized Medical Device User Fee Amendments (MDUFA IV). Under CLIA, clinical laboratories must obtain a certificate to perform complex diagnostic t...
  • Regulatory NewsRegulatory News

    Sen. Warren: Adding UDIs to Medicare Claims Forms Should be a 'No-Brainer'

    Millions of Americans are implanted with various medical devices each year, though the Centers for Medicare & Medicaid Services (CMS) still lacks the ability to track which devices prematurely fail or are recalled based on claims data. At a hearing Tuesday at the Senate Health, Education, Labor and Pensions (HELP) committee, Sen. Elizabeth Warren (D-MA) called on CMS to update the Medicare claims form to include a line for the unique device identifier (UDI) to kno...
  • Regulatory NewsRegulatory News

    When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance

    The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted. The draft highlights criteria for submitting ANDAs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), petitioned ANDAs under section 505(j)(2)(C) ...
  • Regulatory NewsRegulatory News

    CLIA Waiver Decisions: FDA Begins Posting Summaries

    The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part of a pilot to boost transparency. FDA also updated its guidance on its administrative procedures for CLIA categorization for IVDs to reflect new commitments under the recently reauthorized Medical Device User Fee Amendments (MDUFA IV). So far, the agency has posted de...
  • Feature ArticlesFeature Articles

    Bioequivalence Studies of Solid Oral Dosage Forms Overview

    The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US. Introduction 'Generic' drugs offer a significant cost saving and are ...
  • Regulatory NewsRegulatory News

    FDA Finalizes GDUFA Q&A Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized the second part of its question and answers guidance on issues related to the Generic Drug User Fee Amendments (GDUFA), including self-identification requirements, generic drug reviews, and inspections and compliance issues. The guidance, which finalizes a revised draft version released in September 2013, provides answers on more than 30 commonly asked questions on GDUFA implementation. While the draft g...
  • Regulatory NewsRegulatory News

    FDA Looks to Standardize PQ/CMC Data and Terminologies

    The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission. FDA, which is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document, said the move to standardize PQ/CMC data elements and terminologies will improve the efficiency and quality of th...
  • Regulatory NewsRegulatory News

    FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations

    The US Food and Drug Administration (FDA) on Tuesday issued a draft questions and answers guidance to clarify expectations for using electronic systems, including electronic records, cloud computing and mobile technology, in clinical investigations. Specifically, the guidance provides 28 questions and answers detailing how drugmakers, clinical investigators, clinical research organizations (CROs) and institutional review boards (IRBs) can ensure such electronic systems m...
  • Regulatory NewsRegulatory News

    Health Canada to go eCTD-only for Drug Applications

    Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format. As of that date, Health Canada says that sponsors must use eCTD format for all new drug submissions (NDS) and abbreviated new drug submissions (ANDS), as well as supplements to both submission types. The agency also notes that sponsors can request an exemption from the requirement for individual products, but sa...
  • 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...
  • Regulatory NewsRegulatory News

    May Deadline for FDA's eCTD Transition Approaches

    Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) all New Drug Applications (NDAs), Biologics License Application (BLAs) and Abbreviated New Drug Applications (ANDAs) using the electronic Common Technical Document (eCTD). Drug Master Files (DMFs), Biological Product Files (BPFs)...