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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    A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new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...
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    FDA Releases New Electronic Submission Requirements for Biological Products

    A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) outlines a new process of submitting lot distribution reports (LDRs) in electronic format. Background As required by 21 CFR 600.81 , LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted at least every six months, though FD...
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    FDA Initiative to Re-Label Older Drugs Hits Significant Setback: Sources

    A multi-year, $26 million program launched last year by the US Food and Drug Administration (FDA) is now being partially shelved after running into significant difficulties, FDA sources tell Focus . Background The program, known as the Prescription Drug Labeling Improvement and Enhancement Initiative (PDLIEI or PDLI-EI) began in February 2013 when FDA announced its creation in the Federal Register and solicited public feedback on its goals. Simply put, the program i...
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    Australia’s TGA Proposes Major Update of 2001 Labeling Regulations

    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) is seeking comments on multiple proposals for the first major revision of its 2001 Drug Labeling Regulations. The regulations are intended to address safety risks posed by issues such as: The difficulty of finding ...
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    FDA Revises Labeling Guidance to Clarify Clinical Pharmacology Recommendations

    A new draft guidance document published by the US Food and Drug Administration (FDA) seeks to help sponsors with the "clinical pharmacology" sections that accompany an approved drug's labeling. Background Clinical pharmacology refers to how a drug is expected to affect a patient using the drug, and includes information obtained from pharmacodynamic and pharmacokinetic research (i.e. how a drug interacts with the body, and to what extent), as well as from adverse event a...
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    Rare FDA Warning Letter Shows Spanish Drug Claims no Match for Agency Translators

    A Warning Letter issued this week by the US Food and Drug Administration (FDA) to a marketer of pharmaceutical products is a rare example of FDA cracking down on promotional claims made in Spanish and aimed at an audience outside the continental US. Background The 30 June 2014 letter (released to the public on 5 August 2014) is based on FDA's review of a website reportedly owned by a Puerto Rican proprietor, Ramon Rosa. The letter itself is fairly straightforward in ...
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    House Republicans Increase Pressure on FDA Proposal, Citing Agency's 'Dubious' Behavior

    A new group of House legislators is calling on the US Food and Drug Administration (FDA) to answer questions about a plan to overhaul the way in which generic drug labels are updated to reflect new safety risks, saying the plan appears to have been improperly influenced by a special interest group. Background In November 2013, FDA unveiled a new proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products . The rule wou...
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    EMA Tightens Standards for Drug Naming Requests

    European regulatory officials have tightened the standards for obtaining approval for a drug name, reducing the number of proposed names companies can put forth for consideration at any one time. The change, contained in a revised guideline, on the Acceptability of Names for Human Medicinal Products Processed Through the Centralised Procedure , reduces the number of proposed names that may be sent to the European Medicines Agency (EMA) to two invented names. At...