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    Final Rule Allows FDA to Destroy Some Drugs Denied Entry into US

    As part of its efforts to protect the drug supply chain, the US Food and Drug Administration (FDA) is implementing a final rule that will allow it to destroy a drug valued at $2,500 or less that has been refused entry into the US under federal law. Background The final rule -- which is authorized by amendments made to the Federal Food, Drug and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act (FDASIA) -- comes as under existing rules, even if a...
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    FDA to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically

    The US Food and Drug Administration (FDA) is reminding manufacturers and importers of medical devices about an upcoming requirement to submit all adverse event reports electronically. Background The shift was made final in February 2014 under a final rule, Medical Device Reporting: Electronic Submission Requirements . While medical device manufacturers have long been required under 21 CFR 803 to report known or suspected adverse events to FDA, the regulator has tra...
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    European Commission Responds to 'Stop Vivisection' Campaign

    The European Commission (EC) has responded to a campaign calling for an end to animal testing in the EU, saying animal testing is still necessary, but promising to accelerate efforts to reduce the need for animal testing. Background In March 2015, the Stop Vivisection campaign submitted a European Citizens' Initiative to the EC, calling for the commission to repeal Directive 2010/63/EU and replace it with new legislation that would phase out animal testing. A Eu...
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    FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

    • 22 May 2015
    The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week. The announcement, contained in the latest edition of the US Unified Agenda , contains 33 proposed and final rules FDA says it hopes to publish by the end of calendar year 2015. In practice, however, some rules have remained on FDA's Unified Agenda for years. FDA's latest update of the Unified contains two additional regulations compared to its las...
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    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...
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    FDA Grants Approval to New Drug Under Rarely Used Animal Rule Pathway

    A new drug approved by the US Food and Drug Administration (FDA) to treat patients afflicted with the plague was reviewed under a rarely used regulatory pathway meant to sidestep ethical and practical testing concerns. Background In 2002, FDA passed the  Animal Efficacy Rule  ("Animal Rule"), a regulation which permits the approval of some products based on safety testing in humans and efficacy testing in animals. The rule, located at  21 CFR 314.600-650  (drugs) and  ...
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    Trial Lawyers, Favoring FDA's Generic Drug Labeling Rule, Blast Generic Drug Industry Study

    A trade group representing trial lawyers is fighting back against a 2014 report by the generic pharmaceutical industry which claimed a rule proposed by the US Food and Drug Administration (FDA) to allow generic drug companies to help update drug labels could cost the industry billions and raise drug costs for consumers. Background In November 2013, FDA  proposed a rule to allow  generic drug manufacturers to temporarily update their labels if they were made aware of new...
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    FDA's Electronic Drug Labeling Proposal Comes Under Fire

    The US Food and Drug Administration (FDA) is coming under fire from patient safety groups and US legislators who say the agency's attempt to require certain drug labeling information to be distributed electronically instead of on paper "package inserts" could put patients at risk. Background In December 2014, FDA released a long-anticipated proposed regulation, Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Prod...
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    FDA Reopens Debate Over Major Generic Drug Labeling Rule

    Despite rumors of its demise, the US Food and Drug Administration’s (FDA) controversial plan to allow generic drug companies to update their labels to reflect new and emerging safety information isn’t dead—not yet, at least. Background As Regulatory Focus has extensively reported in the past, FDA has long been interested in making it easier for all drug companies—not just innovative manufacturers—to update the safety labeling on drug products. Read our Regulatory ...
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    High Failure Rate for AEDs Prompts FDA Change in Regulatory Policy

    • 02 February 2015
    The US Food and Drug Administration's (FDA) has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to ensure the devices—which have failed in tens of thousands of reported cases since 2005—function reliably when they are needed most. Background The move, which was first announced in 2013 , relates to the way in which FDA approves medical devices. Currently, most hig...
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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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    FDA Scraps Pregnancy Labeling Classification System in Favor of New Standard

    The labeling on many prescription drug products approved after 2001 will need to be reconfigured to include clearer information about whether a drug is safe to use during pregnancy, the US Food and Drug Administration (FDA) announced today. Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce labeling uniformity were first passed. Those measures were substantially updated in 2006 under FDA's ...