• Regulatory NewsRegulatory News

    Researchers Link Target Product Profiles to Shorter Review Times

    A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency. The analysis was published in Cell Press earlier this month by Christopher Breder, a medical officer within FDA's Office of New Drugs and adjunct faculty at Johns Hopkins University's regulatory science program and two students in the program, Wenny Du and Adria Tynd...
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    BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products

    Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations. Background Under what’s known as the pre-request for designation (pre-RFD) program, sponsors can ask FDA how their product will be classified (drug, device, biological product or combination product), and which of the agency's three review centers will be responsible for reviewing and reg...
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    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...
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    European Commission Recommends Changes to SmPC, Package Leaflets

    The European Commission last week released a report detailing recommendations to improve the information provided to patients and healthcare professionals for approved drugs. In its report, the Commission says that the European Medicines Agency (EMA) should update its guidelines to improve the comprehension and readability of package leaflets (PL) and summary of product characteristics (SmPC) to safe use of drugs in the EU. The report itself takes into account the resul...
  • Feature ArticlesFeature Articles

    Global Regulatory Developments in Cell and Gene Therapy, Drug Manufacturing Inspections, Regulatory Intelligence Tools and a Preview of March

    Feature articles over the past several weeks have highlighted the challenges associated with the development of advanced therapy medicinal products, the evolution, potential uses and regulatory aspects of gene therapy, key points of international drug manufacturing inspections published in a new electronic journal by the Chinese Center of Food and Drug Inspection (CFDI) and the relevance of four draft guidances released by the China Food and Drug Administration (CFDA) r...
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    GAO: Drugmakers Want More Clarity on Antibiotic Incentives

    Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO). Specifically, GAO says that FDA has issued 14 updated or new guidances focused on antibiotics since the Generating Antibiotic Incentives Now (GAIN) Act was passed as part of the Food and Drug Admi...
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    Regulatory Intelligence, Leading Edge Technology, Compliance Strategy, Scientific Research and a Preview of February

    The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in February. By Gloria Hall Over the past several weeks, feature articles presented the critical role of regulatory strategy and intelligence in the drug development process, sources for global regulatory precedent, information requirements for an investigational new drug application, benefits of a global web-based information management system, the re...
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    FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety

    More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products. The final rule, first proposed in 2009 , which is the first time the agency has issued specific recommendations for combo products, is part of FDA’s efforts to ensure more consistent postmarketing safety reporting for these drug/device, biologic/device, biologic/drug or drug/biologic/d...
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    Quality and Compliance, Regulatory Research, Policy Issues and a Preview of December

    The following is a summary of feature articles posted throughout November with links and a preview of what's to come in December. Feature articles in November presented common misconceptions about quality control and quality assurance, the importance of developing a robust quality management system, process validation, the appropriate response time for FDA warning letters, regulations for prescription drug advertising, the impact of the 2016 revision of the ISO 13485 s...
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    FDA Begins Intercenter Pilot Project on Combination Products

    The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics. To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving imple...
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    Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn

    The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness. The guidance focuses on a problem that has long plagued the generic industry, as generic labels are required by law to mirror their reference product counterparts at the time of approval but s...
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    FDA Kicks Pharma, Device Rule Finalizations Down the Road, Past Obama’s Presidency

    The US federal government is notoriously slow at promulgating new rules and bringing them into enforcement. But the US Food and Drug Administration (FDA) is taking that slowness to a whole new level for a host of potentially controversial final and proposed rules, some of which have lingered for decades. On Friday, the US Department of Health and Human Services (HHS), which FDA operates under, released its semiannual inventory of rulemaking actions under developm...