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  • Timing of Complete Response Letter Disclosure Leads to Investigation into Novo Nordisk

    • 10 December 2013
    Danish pharmaceutical manufacturing giant Novo Nordisk is the target of a new investigation into whether the company provided adequate disclosure to its investors regarding the status of two drug products it had sought approval for from the US Food and Drug Administration (FDA). Background The investigation, first revealed by Novo in a 10 December 2013 press statement, regards the complete response letters (CRLs) sent by FDA to Novo on 8 February 2013 for two products, ...
  • FDA Finalizes Extensive Guidance on Pivotal Trials for Medical Devices

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released an extensive new final guidance document on the design of pivotal clinical investigations meant to support the approval of medical devices. The 57-page guidance, Design Considerations for Pivotal Clinical Investigations for Medical Devices , was first released in draft form August 2011 and pertains to the stages of development in which a device is evaluated for s...
  • Sterility Violations Form Basis of FDA Warning Letter to Novo Nordisk

    Life sciences manufacturer Novo Nordisk has been sent a Warning Letter from the US Food and Drug Administration for what regulators said were "significant" deficiencies found at the company's Bagsvaerd, Denmark facility. FDA officials said they were particularly concerned about current good manufacturing practice (CGMP) violations found at the firm, which included practice deviations that could have potentially led to product being manufactured under non-sterile condit...
  • FDA Clears Gastroenteritis Diagnostic Device Through De Novo Pathway

    The US Food and Drug Administration (FDA) has announced the clearance of a new diagnostic test it says is capable of simultaneously testing a sample to identify the presence of any of 11 causes of infectious gastroenteritis. Infectious gastroenteritis is a condition FDA explained is marked by the inflammation of the intestines and stomach, and may be caused by viruses, bacteria or parasites. Some of the most common variants include infections caused by salmonella, shig...
  • FDA Beefs up Medical Countermeasure Program with new 510(k) Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry regarding the development of In Vitro devices capable of detecting the presence of several types of dangerous pathogens, its latest effort in a long-running strategy to develop medical countermeasures (MCMs). The guidance, released 9 November 2012, specifically addresses the unique needs of conducting clinical trials on such a device. The clinical testing of products used to tr...
  • FDA Clears Ingestible Medical Device Aimed at Boosting Adherence

    The US Food and Drug Administration (FDA) has cleared an ingestible medical device manufactured by Proteus Digital Health through its de novo clearance pathway, clearing the way for the futuristic device to get to market. The de novo process is used for low-risk novel devices that would otherwise be required to submit a premarket approval (PMA) application and be subjected to expensive clinical trials. Proteus' device, the Ingestion Event Marker (IEM), was described...
  • Feature ArticlesFeature Articles

    Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

    The US court system has been busy recently with issues affecting the pharmaceutical industry, including a number of cases involving the Hatch-Waxman Act. On 17 April 2012, the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S marking the first Abbreviated New Drug Application (ANDA) case decided by the high court since the passage of the act in 1984. The Supreme Court has a long history of overturning Federal C...
  • Public Citizen to FDA: Diabetes Drug Unsafe, Should Be Pulled

    The watchdog group Public Citizen is calling on the US Food and Drug Administration (FDA) to yank Novo Nordisk's diabetes drug Victoza (liraglutide) off the market for safety risks it says "outweigh any documented clinical benefits." After being approved, "the watchdog group says a review of the FDA adverse event database found 200 patients were diagnosed with acute pancreatitis during the first 17 months that Victoza was available, suggesting a larger number of [thyroid...
  • Supreme Court Rules Company Can Sue Novo Nordisk For Delaying Generic Medication

    • 18 April 2012
    The Supreme Court of the United States ruled 17 April that Caraco Pharmaceuticals can proceed with a lawsuit against Novo Nordisk over Nordisk's purported attempts to prevent Caraco's generic entry into the market, reports various news sources. "At issue was the ability of a brand-name drugmaker to block generic competition by providing the US Food and Drug Administration (FDA) with overly broad descriptions of its patents," writes  Pharmalot . Caraco's lawsuit a...
  • Report: Comments on Draft Biosimilar Guidelines Mostly Trend Negative

    Comments on the US Food and Drug Administration's (FDA) February 2012 draft guidance documents on biosimilar are mostly negative and reflecting discontent with the required studies to prove biosimilarity , reports Genetic Engineering & Biotechnology News (GEN) . In comments submitted to the Federal Register during FDA's comment period, several large biopharmaceutical manufacturers and patient organizations expressed their views on the trio of guidelines, which we...
  • CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions. FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , was released 27 March 2012. FDA noted at the time of the guidance release ...
  • FDA Releases New Guidance For Industry for Benefit-Risk Evaluations in PMAs, De Novo Classifications

    The US Food and Drug Administration (FDA) released new guidance on 27 March for benefit-risk determinations in premarket approvals (PMAs) and de novo classifications for medical devices. The guidance, Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , "is intended to provide greater clarity on FDA's decision making process," FDA wrote. According to the guidance document, "this guidance sets o...