• Regulatory NewsRegulatory News

    Obama Approves Bill Reforming Regulation of Sunscreen Ingredients, Other Drugs

    US President Barack Obama has signed into law a new bill set to change the way in which some drugs, and in particular sunscreen ingredients long approved in other countries, are regulated by the US Food and Drug Administration (FDA). Background The bill, the Sunscreen Innovation Act (SIA), was signed into law by Obama on 26 November 2014 following its passage in the House of Representatives on 14 November 2014. The bill's passage follows extensive complaints by s...
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    FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show

    A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking. Background FDA, like any other federal agency, takes actions in response to a wide range of factors. It may, for example, implement a new policy at the explicit direction of ...
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    New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Health Canada, Canada’s medical device market regulator, has published new  guidance  requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications. Set to take effect 1 December 2014, the new rules will require Class III and IV MDL applicants to submit premarket review documentation...
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    Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

    Senate legislators have released a new iteration of the Sunscreen Innovation Act , a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs. Background As explained in our article on the House version of the Sunscreen Innovation Act , the bill has long been focused on the Time and Extent (TEA) application ...
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    House Legislators Clear Sunscreen Innovation Bill, but Questions Remain

    The US House of Representatives has voted in favor of a bill that would require the US Food and Drug Administration (FDA) to speed up its assessment process for new sunscreen ingredients that have been awaiting regulatory approval for as long as a decade in some cases. Background The bill, the Sunscreen Innovation Act (H.R. 4250) requires FDA legislators to speed up their review of sunscreen ingredients submitted under the Time-and-Extent Application (TEA) process. ...
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    FDA Wants to Make Product Recalls Easier to Track

    A little more than a month after first launching its long-anticipated openFDA project, the US Food and Drug Administration (FDA) has announced that it hopes the project can do for product recalls what it has already done for adverse event data. Background The openFDA initiative was born from a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and...
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    Sunscreen Innovation Act Advances in House, Seeks FDA Action on New Ingredients

    Legislators are preparing to move forward with legislation that would require the US Food and Drug Administration (FDA) to take action on the approval of new sunscreen ingredients, a collection of which have been pending before the agency for years, and in some cases more than a decade. Background HR 4250 , known as the Sunscreen Innovation Act , is co-sponsored by Reps. Ed Whitfield (R-KY) and John Dingell (D-MI) and required FDA legislators to speed up their r...
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    There's an App for That: China FDA Launches Mobile Drug Regulation Application

    The China Food and Drug Administration (CFDA) has launched a "national food and drug regulation" application, or "app," that permits the user to directly access the agency’s rules, regulations, working papers, drug quality announcements, medical device quality bulletins, drug and device recall information, and press releases. The application works with iPhone and Android phone operating systems and was developed as part of what the Chinese government cal...
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    FDA Launches Big Data 'openFDA' Initiative, Giving Public Easier Access to Safety Information

    The US Food and Drug Administration (FDA) has launched a long-awaited technology initiative intended to free regulatory data that was once difficult to obtain and harder still to make sense of. Background The initiative, known as openFDA, comes in the wake of a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public....
  • FDA: More Than 3.4 Million Hours Spent Each Year Filing New and Generic Drug Applications

    It's well known that preparing a new or abbreviated new drug application (NDA/ANDA) for the US Food and Drug Administration (FDA) is a long, arduous and time-consuming affair. And according to new data just released by the agency, it would seem that popular wisdom is indeed correct. Background On 24 March 2014, FDA put out a call for public comment on its drug application processes , which are used to support the approval of all new and generic chemical drugs, as well ...
  • New FDA Document Clarifies IND Process for Drugs, Biologics and Biosimilars

    A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new drug (IND) applications. INDs are used by pharmaceutical and biotechnology companies at the relative start of the new drug application (NDA) and biologics licensing application (BLA) process, and once approved allow sponsors to begin the clinical testing phase of product dev...
  • Centralized Procedure to see Simplified Submission Process, Says EMA

    The European Medicines Agency (EMA) has announced that it has simplified the process by which marketing authorization applications (MAAs) are submitted to the agency, reducing the number of applications that marketing authorization holders (MAHs) need to submit during the centralized procedure. The changes comes just as EU regulators are in the midst of implementing the pharmacovigilance legislation, an EU-wide set of requirements intended to make it easier to track and ...