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  • Regulatory NewsRegulatory News

    FDA Makes Drug Safety Labeling Change Information Easier to Access

    The US Food and Drug Administration (FDA) on Thursday announced the safety labeling changes (SLC) program will be managed by its Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM), which has created a new database that provides data to the public in downloadable and searchable formats. “With this transition, safety labeling change (SLC) data on the Web will now be available much faster for health care providers, health information technol...
  • Regulatory NewsRegulatory News

    Seven Pharmaceutical Regulators and NIH Collaborate to Build Drug Ingredient Database

    Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information. The database, known as Global Ingredient Archival System (ginas), provides a common identifier for all APIs and provides a consistent definition of substances globally, consistent with the ISO 11238 standard . The effort, which its developers describe as similar ...
  • Regulatory NewsRegulatory News

    UDI Compliance: What's Coming From FDA in 2016

    Class II medical devices will follow Class III and implanted devices later this year when they come into compliance with unique device identifier (UDI) regulations beginning in September, officials from the US Food and Drug Administration (FDA) told the UDI Conference in Baltimore on Monday. Under the UDI rule, FDA established a phased, risk-based, approach to UDIs, which are tracking tags used to improve the safety of medical devices. The rule began applying to Class II...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: UK Plans Off-Label, Experimental Drug Database (4 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Backs Plan to Create Database of Off-Label and Experimental Treatments The United Kingdom government has thrown its weight behind legislation that would result in the creation of a database of innovative treatments being carried out by doctors in England, including both off-label uses of existing drugs and tests of unlicensed, experimental therapies. Official...
  • Regulatory NewsRegulatory News

    FDA Looks to Curate Genetic Databases to Support NGS Validation

    Experts met at the US Food and Drug Administration (FDA) today to discuss how curated databases could be used to establish the clinical relevance of genetic variations, and how the agency could use these databases to evaluate next-generation sequencing (NGS) diagnostics. NGS tests have the ability to quickly sequence the human genome and identify thousands of genetic variants. However, as Erin Ramos of the National Human Genome Research Institute put it, our "ability to ...
  • Regulatory NewsRegulatory News

    FDA Pushes GUDID Compliance Back for Some Devices Due to Security Flaw

    After discovering a security flaw in the Global Unique Device Identification Database (GUDID), the US Food and Drug Administration (FDA) is giving device makers an additional month to comply with new labeling and data submission requirements. Background In 2013, a new set of regulations required companies to comply with new labeling and data submission requirements, with staggered compliance dates based on device classification. Specifically, companies distributing dev...
  • Regulatory NewsRegulatory News

    FDA's Holiday Gift to Industry: Easy-to-Search Guidance Documents

    The holidays may be over, but the US Food and Drug Administration (FDA) has just given regulatory professionals around the world an unexpected gift: a unified, easy-to-view database of guidance documents issued by the agency. Editor's note: A previous iteration of this story noted the database currently contains all guidance documents issued by the agency. That statement was premature. The database currently contains many--but not all--guidance documents. We regret the ...
  • Feature ArticlesFeature Articles

    US UDI/GUDID Submission Deadlines: What Medical Device Manufacturers Need to Know

    The US Food and Drug Administration (FDA) Unique Device Identification (UDI) final rule, 1 released 24 September 2013, requires medical devices distributed in the US to include a UDI value on the device label and package. The UDI combines a static device identifier, assigned by an FDA-approved issuing agency, and a series of dynamic production identifiers, taken from information on the device’s label. The rule also requires medical device manufacturers to submit ...
  • Regulatory NewsRegulatory News

    In New Transparency Bid, EMA Expands Drug Adverse Event Reporting Database

    The European Medicines Agency (EMA) is making it easier for patients and industry to keep track of adverse events associated with medicines authorized for use by EMA and other national drug regulatory authorities. Under a massive expansion of EMA's existing ADRreports.EU website, which houses the European database of suspected adverse drug reaction (ADR) reports, consumers can now view suspected ADR reports for drugs regardless of their centrally authorized approval st...
  • Regulatory NewsRegulatory News

    FDA Unveils Final Details about Medical Device Tracking System

    Regulators with the US Food and Drug Administration (FDA) have released a second, substantially more complete guidance document indicating how its Global Unique Device Identification Database (GUDID), an integral part of the agency's pending oversight of the Unique Device Identification (UDI) system, works. Background Under FDA's UDI regulation, medical device manufacturers will soon have to start affixing device identifiers and production identifiers to most devi...
  • Regulatory NewsRegulatory News

    FDA Releases Final, Slimmed-Down GUDID Guidance, Leaving Many Details for Later

    The US Food and Drug Administration (FDA) has finalized a guidance document intended to outline the appropriate use of its Global Unique Device Identification Database (GUDID), an integral part of its attempt to overhaul how medical devices are kept track of in the US. But not included in the final guidance is more than half of what the agency originally set out to define. Background A Unique Device Identification (UDI) is, as its name implies, a system of identif...
  • Focus' Federal Register Tracking Tool for the Life Science Industry (Updated 25 July 2013)

    Notice: This page is no longer being updated. The Federal Register Tracking Tool can now be found at the following link, where it is updated regularly:  http://www.raps.org/focus-online/federal-register-tracking-tool.aspx Here at Regulatory Focus , we read the US government's Federal Register like some people check their Facebook pages, which is to say obsessively. When it comes to keeping track of what the US Food and Drug Administration (FDA) is doing - f...