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    EC Previews Call to Set up Expert Panels for EU MDR/IVDR

    The European Commission (EC) said on Friday it will issue a call for applications to set up the expert panels for the premarket product evaluation consultation procedures provided under the EU’s medical device regulation (MDR) and in vitro diagnostic regulation (IVDR).   The EC is preparing to designate the new expert panels that will support the assessments for certain medical device classes and IVDs. The EU legislation obliges the EC to establish the expert panels ...
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    FDA Finalizes Guidance on Advertising and Promotional Material Submissions

    The US Food and Drug Administration (FDA) on Friday finalized guidance on the requirements and recommendations for submissions of promotional materials for prescription drugs and biological products, including the specific formats needed. The 37-page guidance, drafted in April 2015, describes the various types of voluntary submissions (e.g., launch and non-launch submissions of draft promotional materials for comments) and required submissions of promotional labeling an...
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    New Study Questions the Need for 12 Years of Market Exclusivity for Biologics

    The lengthy preclinical and clinical development necessary to bring a biologic to market has often been cited as one of the central reasons why biologics deserve 12 years of market exclusivity, or about five years more exclusivity than their small molecule counterparts. But a new study published Tuesday in Nature Biotechnology shows that the development time of a new biologic is generally about the same as the development time of a small molecule drug. The authors ...
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    FDA Releases 20 Years of Data on Medical Device Adverse Event Reports

    The US Food and Drug Administration (FDA) recently ended its Alternative Summary Reporting (ASR) program for medical devices, revoked the related exemptions and on Friday made available on its website all adverse event reports received under ASR exemptions from 1999 to 2019. FDA said it initially indended the ASR program to be for “specific well-known and well-characterized events associated with specific devices,” and that exempted submissions excluded events where the...
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    Paclitaxel-Coated Devices’ Late Mortality Signal Not Well Understood, FDA Panel Hears

    Following Wednesday’s debate on missing data necessary for paclitaxel-coated devices’ mortality assessments, the US Food and Drug Administration (FDA) advisory committee on Thursday offered recommendations on how to use what is in place to understand mortality signals.   Limited data on dose effect, toxicity and other potential factors have posed barriers for FDA and industry to achieve a complete understanding of paclitaxel- or drug-coated balloons (DCBs) and paclitaxe...
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    FDA’s OPDP Sends Third Untitled Letter of 2019

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently released its third untitled letter of 2019 because of a direct-to-consumer video on Aclaris Therapeutics’ Eskata (hydrogen peroxide) that failed to adequately present the drug’s serious risks. The video, which originally aired on ABC’s The View last September, does not include “prominent, balancing risk information about Eskata,” OPDP said, noting that it is indicated f...
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    Iran, Argentina Join International Drug Regulators Group

    Regulators from Iran and Argentina have joined the International Pharmaceutical Regulators Programme (IPRP) as members, the IPRP announced following its third management committee meeting in Amsterdam earlier this month.   Less than a year after its first management committee meeting , IPRP’s membership has expanded to 26 members and two observers with the addition of Iran’s National Regulatory Authority (NRA) and Argentina’s National Administration of Drugs, Foods an...
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    FDA Advisory Committee Calendar

    Regulatory Focus is pleased to team with Tarius , a regulatory information services provider, to routinely offer information about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner. Upcoming Meetings   25 July – Arthritis Advisory Committee The committee will discuss a supplemental new drug application (sNDA) for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the trea...
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    FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

    The US Food and Drug Administration (FDA) on Thursday released new draft guidance on its benefit-risk assessment framework for opioids, outlining how the agency plans to compare the effectiveness and safety of new opioids with already approved opioids. The idea for a comparative approval standard, discussed by former FDA Commissioner Scott Gottlieb in March before a Senate committee, hinges on the fact that “FDA believes that there should be a premarket demonstration ...
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    EU Regulatory Roundup: EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit   The European Medicines Agency (EMA) has begun preparing its Clinical Trials Information System (CTIS) for audit. EMA performed testing and bug fixing of the single entry point for clinical trial information earlier in the year, positioning it to now enter “a phase of agile, iterative ...
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    EU MDR/IVDR: MedTech Europe Looks to Tackle Implementation Delays

    MedTech Europe outlined a 7-point plan to aid EU member states in implementing the medical device and in vitro diagnostic regulations’ (MDR/IVDR) new system with greater efficiency and at a faster pace. With the increasing urgency to implement the new regulatory system on time, the 7-point plan serves as a call to action. It covers notified bodies (NBs), product re-certification, Eudamed, guidance, scientific bodies, delegated and implementing acts as well as harmoniz...
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    FDA Panel Faces ‘Conundrum’ with Mortality Assessments on Paclitaxel-Coated Devices

    Discussions at the first day of a two-day US Food and Drug Administration (FDA) advisory committee meeting cited a large amount of missing data and other flaws in conflicting analyses as barriers to finding a mechanism responsible for the increased late mortality rates linked to using paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs). FDA officials, experts in the FDA-convened committee and industry agreed that limitations in mortality assessments r...