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    FDA to Systematically Incorporate Patient Preferences into Device Approvals

    US medical device regulators at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) have unveiled a proposed framework for the collection and use of patient preference information (PPI) in medical device development. Background The new draft guidance document, Patient Preference Information –Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling , is closely related to CDRH's...
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    The Tip of the Iceberg: What Lurks Beneath the 483

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.  The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com . At the end of a grueling week spent sitting in a conference room with an in...
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    The Essential Guide to Finding FDA Information on Drugs, Medical Devices and Biotech

    Let's face it: Finding regulatory information can be difficult. Maddeningly difficult. Anyone interested in finding information about the US Food and Drug Administration (FDA) needs to have an almost encyclopedic knowledge of the regulator's website to find relevant information, to say nothing of the dozens of other government websites which house regulatory information or non-governmental websites which make finding information easier. What if there were an easier way t...
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    EMA to Translate Safety Signal Recommendations

    In an effort to improve the timeliness and consistency of product information changes, the European Medicines Agency (EMA) is now translating recommendations in all official EU languages, plus Icelandic and Norwegian. Background In the EU, pharmaceutical companies are required to provide translations of product information to EMA after a product is authorized. The translations must be made in all official EU languages, including Icelandic and Norwegian. From time to ...
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    FDA Proposal Calls for Drug Labeling to be Distributed to Doctors Electronically

    In a long-anticipated and major move, the US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically. Background The proposed rule , Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products , comes after years of development at FDA. Under Section 1140 of the 2012 Food and Drug Administratio...
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    In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims

    The US Food and Drug Administration's (FDA) drug advertising oversight division has sent a warning to a pharmaceutical company regarding materials used to promote a drug, saying the materials omitted "important risk information" and contained claims about the drug's superiority that did not hold up to the agency's close scrutiny. The Letter In its so-called " Untitled Letter " to New Jersey-based Sciecure Pharma, FDA's Office of Prescription Drug Promotion (OPDP) said i...
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    FDA's Long, Long Search for a Chief Information Officer

    The US Food and Drug Administration (FDA) is having a difficult time finding a suitable candidate for its vacant chief information officer (CIO) position. Background FDA has been without a permanent CIO since March 2013, when Eric Perakslis, formerly of Johnson & Johnson, left the agency after just six months . The position has been filled on an acting basis since then by Walter Harris , who is also FDA's deputy commissioner for operations. As FierceBiotechIT note...
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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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    9 Free Tools Regulatory Professionals Can use to Monitor the Regulatory Landscape

    It can be profoundly difficult to monitor—let alone make sense of—the regulatory affairs environment. Thanks to constantly changing laws, regulations, policies, legal developments, technologies and sources of information, regulatory professionals need all the help they can get to conduct regulatory surveillance. Luckily, even for regulatory professionals without a budget, there are several free tools and websites that can help you find information, stay ahead of your pee...
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    FDA to Provide Guidance on Use of Economic Information, Responses to Unsolicited Requests

    US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information. Background The US Food and Drug Administration (FDA) recently released two draft guidance documents intended to clarify how it treats scientific and medical literature. The first of those guida...
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    Regulatory IQ: The Power of Regulatory Intelligence

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com . Regulatory professionals know that what it takes to succeed is, more t...
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    Congress Skeptical About FDA, ONC Effort to Coordinate on Health IT Regulation

    In April of this year, the US Food and Drug Administration (FDA), along with the Office of the National Coordinator for Health Information Technology (ONC), issued a new proposed framework indicating their desire to more consistently regulate health technology, including health software. Now members of Congress have written to the ONC regarding that proposal, saying parts of it go above and beyond its authority under the law. Background In 2012, the  Food and Drug...