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    Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances

    With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label. Introduced in January, the draft Q&A documents detail how drug and device firms can discuss unapproved medical products with payers in ways that are "truthful and non-misleading," as well...
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    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    BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products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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    Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council

    Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements. J&J calls on FDA’s new council to address the process and principles for determining the primary mode of action with cross-center collaboration to ensure technical considerations are included in the dec...
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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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    Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Offers Fast-Track Approvals to HIV, Hepatitis Combination Products The Drug Controller General of India (DCGI) is offering fast-track approvals to combination products to treat HIV and hepatitis B and C. DCGI Dr GN Singh is prepared to waive the need to run clinical trials and truncate the regulatory submission process to cut the time it takes for sponsors to br...
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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...
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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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    EMA Weighs New Guideline on Quality Requirements for Combination Products

    The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product. EMA says the guideline will consider the data requirements with respect to quality aspects in relation to the safety and performance of the medical device, whether it is an integral component of the medicinal product or a stan...
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    FDA Details Combination Product Postmarket Safety Reporting Requirements

    The US Food and Drug Administration (FDA) is looking to clarify its expectations for combination product manufacturers adjusting to the agency's recently released final rule for postmarket safety reporting. In a webcast last week, John Weiner, associate director for policy at the Office of Combination Products (OCP), explained which parts of the rule manufacturers should be following now, and which will they will be required to comply with beginning July 2017. Weiner ...
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    Human Factors Studies for Generic Combo Products: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Friday continued its flurry of draft guidance for generic drug companies (releasing its third in the last two days ), this one for potential applicants planning to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug and a delivery device. The draft comes as the controversy over Mylan’s EpiPen has simmered down, though the only current gener...
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    FDA Offers Draft Guidance on New Pre-Request for Designation Process

    After announcing a new program for sponsors to request earlier, informal input on combination product designations last August, the US Food and Drug Administration (FDA) has issued a new draft guidance detailing how to prepare such requests. Specifically, this program, referred to as pre-request for designation (pre-RFD) program, allows sponsors to ask FDA how their product will be classified (drug, device, biological product or combination product), and which of the age...