This article provides some best practices to align regulatory documents with strategic goals, allowing regulators to understand what a sponsor is trying to achieve, why this goal is important, and how the totality of available information supports the desired regulatory action. Adopting the perspective of a regulatory agency audience, using clear structure and language, and leading teams skillfully are key elements of successful regulatory medical writing.   Keywords ...

European regulators on Tuesday announced the adoption of a common electronic product information (ePI) standard for human medicines that can be accessed by users and healthcare providers alike.   ePI is beneficial because it can be updated and disseminated to stakeholders immediately, without having to wait for new information to be formatted and printed, European Medicines Agency officials said in a statement . EMA released the standard along with the European Commis...

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance to assist sponsors in using an electronic template for submitting a premarket notification 510(k).   In the draft guidance , FDA said it will accept the electronic Submission Template and Resource (eSTAR) template for applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).    The guidance implements section 745(A)(...

A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings, as well as best practices for ensuring smooth reviews.   Susannah Gilbert, Q-submission program lead with the division of regulatory programs at FDA’s Center for Devices and Radiological Health (CDRH), gave the updates at a 21 July webinar sponsored by the FDA’s Small Business Regulatory Education for Industry...

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...

As part of its work to improve and modernize the quality assessment of drug applications, the US Food and Drug Administration (FDA) is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics . The authors describe KASA as a new s...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday said it will conduct a small pilot project to test the processing and analysis of nonclinical study data provided electronically using an updated standard, known as the SEND 3.1, from the Clinical Data Interchange Standards Consortium (CDISC). CDER is seeking a maximum of five participants for the pilot, which will evaluate the compliance of sample SEND 3.1 datasets subm...

Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of the year, with new draft nonclinical and clinical recommendations. CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patien...

The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications. The finalization follows concerns raised by AdvaMed and BIO with the 2016 draft guidance’s lack of language to address the issue of antimicrobial susceptibility breakpoints among drug and medical device sponsors. The issue relates to leveraging the use of ka breakpoint as a vehicle for a...

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,...

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Monday released draft guidance offering recommendations on the use of standards in product development and the use of such standards in CBER’s managed review process. The draft describes how standards are developed, the benefits of using standards and CBER’s policy on accepting standards used in regulatory submissions. Questions and answers contained within the draf...

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017. Over a six-year period, the report says CDRH observed a more than 500% increase in the number of pre-market submissions that include PRO measures. And in FY 2017, more than 75% of approved, pivotal original and new study investigational device...