• Regulatory NewsRegulatory News

    FDA issues final guidance on providing regulatory submissions in alternate electronic formats

    The US Food and Drug Administration on Thursday issued a final guidance to assist sponsors in using alternate electronic formats for submitting applications that are exempt from electronic common technical document (eCTD) filing requirements.   The guidance contains few changes from the draft issued in March 2020. (RELATED: FDA Drafts Guidance on Alternate Electronic Formats, Announces Support for New Data Standards , Regulatory Focus, 10 March 2020 ). In its fina...
  • 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 Updates Orange Book With Patent Submission Dates

    As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine the earliest date when they may be able to market new generics. FDA began collecting the patent submission date data in 2013, and the agency says there are about 4,000 patent records for which submission dates are available. The update is the result of a final rule fr...
  • Regulatory NewsRegulatory News

    FDA Revises Priority ANDA Draft Guidance

    The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA). As part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA II), FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a pre-submission facility correspondence (PFC) at leas...
  • Regulatory NewsRegulatory News

    Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'

    A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster abbreviated new drug application (ANDA) reviews. In June, FDA released the draft guidance noting that it is "critical" for there to be a two-month lead time to determine whether facility inspections will be needed for the 8-mon...
  • Regulatory NewsRegulatory News

    EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias

    Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable. "While we acknowledge the need to avoid and manage any risk of bias, experience over the years shows that such risk can be managed by having in place the necessary safeguards and I can assure you that the Agency guarantees...
  • Regulatory NewsRegulatory News

    FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II

    Now that the FDA Reauthorization Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs). FDARA, which was signed by President Donald Trump last Friday , includes statutory provisions that will expedite the review of qualifying ANDAs by allowing the “pre-submission” of certain information prior to s...
  • 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

    Priority Generic Drug Reviews: New FDA Draft Guidance

    In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II) , the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs. Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their a...
  • 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...