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  • Regulatory NewsRegulatory News

    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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    With US' First Biosimilar Approval Expected This Week, is FDA's Biosimilar Labeling Guidance Imminent?

    The US Food and Drug Administration (FDA) quietly confirmed last week that it planned to release its long-sought biosimilars labeling guidance document sometime in 2015. But with the agency expected to approve the US' first biosimilar, Sandoz' Zarxio (filgrastim, EP2006), as early as tomorrow (6 March 2015), there's a good chance the biopharmaceutical industry won't have to wait long for the release of that guidance. Background At issue is the nomenclature syst...
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    FDA to Publish Biosimilars Labeling, Generic Opioids Guidance Later This Year

    US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs. News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the ...
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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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    Up in Smoke: Canadian Regulators Find Pot too Potent

    A licensed medical marijuana producer in Canada has issued a recall for its pot-based product, saying some batches of it are too strong. According to an information update on the Health Canada website, third party tests of samples of its "Nice N'EZ" product were found to exceed the product’s labeled strength for delta-9-tetahydrocannabinol, marijuana's active ingredient. Background Medical marijuana ( spelled ‘marihuana’ in some official documents) has been regulat...
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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 ...
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    FDA Orders New Warnings on OTC Acetaminophen Drugs

    A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious skin reactions. Background The new guidance, Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions , follows a 2013 warning by FDA that ...
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    FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants

    The US Food and Drug Administration (FDA) is granting labelers of certain types of implantable medical devices a temporary reprieve from its upcoming requirements that all medical device products be marked with a unique device identifier (UDI) meant to make the devices safer. Background A UDI is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulators. "The unique device identification ...
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    Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal

    The generic pharmaceutical industry's most prominent trade body, the Generic Pharmaceutical Association (GPhA), is threatening to sue the US Food and Drug Administration (FDA) if the agency finalizes a change in its labeling regulations that would make it easier for generic drug companies to update their product's labels in response to adverse events. Background Under the Federal Food, Drug and Cosmetic Act (FD&C Act) , generic drug products must—with minor exceptions—...
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    FDA to Test out New Standardized Medical Device Labels in Proposed Study

    The US Food and Drug Administration (FDA) plans to study whether it could standardize device labeling with the use of new content and format standards now under development. Background At present, there are no regulations defining a standardized approach for how content should be structured or formatted for medical devices. This is considerably different than the requirements for other FDA-regulated products, such as food or pharmaceutical products, which must adhere to...