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  • Regulatory NewsRegulatory News

    FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

    New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards. Background The draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States , is closely related to a rule proposed by FDA in February 2013. That rule, Hum...
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    Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies

    A new guidance document issued by the US Food and Drug Administration (FDA) is meant to outline the agency's expectations for meetings that take place between FDA and a sponsor before and after the submission of a new chemical or biological drug product. Background Since the passage of the original Prescription Drug User Fee Act (PDUFA) in 1992, the pharmaceutical and biopharmaceutical industries have helped to fund the operations of FDA through payments of so-called ...
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    How can FDA be Improved? Patient Groups Offer Ideas

    More than a dozen patient groups and trade associations are offering their advice to the US Food and Drug Administration (FDA) on ways the agency can improve its regulatory and administrative processes to take into account the views and expertise of patients and their advocates. Background Since 2012, FDA has launched several initiatives meant to better take into account the views of patients. Some, like its patient-focused drug development initiative , have involv...
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    FDA Explains How its New Incentive Program for Rare Pediatric Disease Treatments Works

    The US Food and Drug Administration (FDA) has released a long-anticipated guidance document intended to explain how a new incentive program known as the Rare Pediatric Disease Priority Review Voucher system works. Background Created in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) , the Rare Pediatric Disease Priority Review Voucher is modeled closely off a similar program known as the Tropical Disease Priority Review Voucher system. T...
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    FDA System to Keep Track of Drug Manufacturers Nears Completion

    A new guidance published by the US Food and Drug Administration (FDA) establishes a specification by which all drug establishments will be identified under a recently established tracking system. Background Under the  Food and Drug Administration Safety and Innovation Act ( FDASIA )  of 2012, both domestic and foreign facilities whose products are imported into the US are now required to register with FDA. Specifically:  ''During the period beginning on October 1 a...
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    Is FDA Listening Enough to Patients? Agency Wants Feedback

    When Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in 2012, its patient-centered provisions were among the biggest changes set to impact the culture of the US Food and Drug Administration (FDA). Now, two years later and with major planning already underway regarding the future of FDA's patient-centered activities, agency regulators are reaching out to the public to ask what more they can do to improve their efforts. Backgr...
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    Manufacturer of Viagra-Laced Supplements Tried to Hide Records from FDA, Agency Claims

    In one of the most unusual Warning Letters sent by the US Food and Drug Administration (FDA) this year, a dietary supplement manufacturer has been chided by regulators for allegedly failing to allow an inspector to fully inspect the facility, allegedly because the products manufactured there contained an active ingredient also contained in Pfizer's Viagra. Background As recounted in FDA's 26 September 2014 Warning Letter, FDA inspectors arrived at Pennsylvania-based Nov...
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    FDA Seeks Patient Insight Into Autism, Depression and 14 Other Conditions

    The US Food and Drug Administration (FDA) has announced a second batch of meetings intended to facilitate the development of drugs for neglected conditions by taking into account the perspective of the patients suffering from the conditions. Background In recent years, some patient groups—and in particular groups representing patients suffering from serious diseases with few or no suitable treatments—have begun to express their concerns that FDA is too stringent when it...
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    Australia’s TGA Clarifies Drug Approval Process in New Document

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week issued a new question and answer (Q&A) guidance  concerning the registration process for new prescription drugs, as well as how to make changes to an already registered product that involves clinical, nonclin...
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    FDA Outlines New Communication Process for Generic Drug Companies

    The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, this time explaining the nuances of how generic drug companies can submit requests for information from the agency. Background GDUFA was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) , and is modeled off other FDA user fee programs such as the Prescription Drug User Fee Act (PDUFA) and the Med...
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    FDA Unveils Policies Meant to Boost Safety, Efficacy of Medical Products for Women, Minorities

    The US Food and Drug Administration (FDA) has released new recommendations on the inclusion of women and other minorities in clinical trials, citing the need to better represent populations which have historically not been adequately included in clinical research. Background When the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was Section 907. The section required FDA to publish a report "addre...
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    Following Criticism, FDA to Focus on Female Sexual Disorders at Upcoming Patient Meeting

    The US Food and Drug Administration (FDA) this week quietly announced that it soon plans to hold a meeting on female sexual dysfunction (FSD) as part of a larger effort to bring patients into the drug development process to fine-tune its benefit-risk assessment process. Background The meeting will be the 11th under FDA's Patient-Focused Drug Development process—an initiative created under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to he...