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    Conducting a Successful Advertising and Promotion Review of Restricted Medical Devices

    This article provides insight for regulatory professionals regarding developing a successful advertising and promotional review of restricted medical devices. It demonstrates how medical device manufacturers and pharmaceutical companies can improve communication and collaboration between regulatory and marketing to streamline and improve the compliance review process for promotional materials and achieve an effective marketing strategy. The Dance "How small can I make...
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    Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022

    President Donald Trump late Friday signed a bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars and medical devices through 2022. Taking effect 1 October, the 86-page law (the text of which can be found here ) passed the House via voice vote in July and by a vote of 94-1 in the Senate earlier this month without the addition of any controversial amendments. The law ensures the ag...
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    EMA and FDA Look to Facilitate Development of Gaucher Disease Treatments

    The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Monday released a new strategy document to aid in the development of new treatments for Gaucher disease, a rare lysosomal storage disorder. Given the limited number of patients worldwide with Gaucher disease, EMA and FDA put forth two possible approaches to better facilitate investigations of such products: Extrapolation across age groups within a single drug development program...
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    FDA Plots Elimination of the Orphan Drug Designation Request Backlog

    With a flood of new orphan drug designation requests, the US Food and Drug Administration (FDA) on Thursday released its new plan to eliminate the backlog of requests in 90 days and to respond to 100% of all new orphan drug designation requests within 90 days. In 2016, the Office of Orphan Products Development (OOPD) received 568 new requests for designation – more than double the number of requests received in 2012. According to FDA’s database of 4,174 orphan d...
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    EMA Consults on Regulatory Requirements for Chronic Liver Disease Drugs

    The European Medicines Agency (EMA) on Thursday launched a public consultation to gather input on a future reflection paper discussing the regulatory requirements for developing drugs to treat chronic non-infectious liver diseases. According to the agency, there is an unmet medical need for drugs to treat chronic non-infectious liver diseases such as non-alcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). And wh...
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    FDA Issues New and Revised Guidance for Generic Drugs

    The US Food and Drug Administration (FDA) on Tuesday released a batch of 21 new and 16 revised draft guidances intended to help drugmakers conduct the studies needed to support the approval of certain generic drugs. Since formalizing its process for making such guidance available in 2010, FDA has published hundreds of product-specific bioequivalence guidances for various products. This is FDA's fourth recent release of new and revised bioequivalence guidance for generi...
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    FDA Officials Discuss Modernizing the Regulation of Combo Products

    As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature . Nina Hunter, FDA’s associate director for science policy, and Rachel Sherman, F...
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    FDA Approves First Treatment for a Form of Batten Disease

    The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV). FDA approved Brineura (cerliponase alfa) to slow the loss of walking ability in symptomatic pediatric patients three years old and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency. ...
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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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    WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site

    A Chinese manufacturer of the active pharmaceutical ingredient (API) for the birth control drug levonorgestrel has been placed on the US Food and Drug Administration’s (FDA) import alert list, causing the World Health Organization (WHO) to scramble to find a replacement. "At the moment, there is no alternative levonorgestrel API which has been prequalified," WHO said Wednesday. When an API is prequalified by WHO, it can be used for the manufacture of finished pharmaceuti...