Sterling IRB 2013 Holiday Closures

Sterling IRB will be closed in observance of the following holidays:

  • November 27th, 2013 - Thanksgiving (closed at 3pm EST)
  • November 28th, 2013 - Thanksgiving
  • November 29th, 2013 - Thanksgiving
  • December 24th, 2013 - Christmas Eve (closed at 2pm EST)
  • December 25th, 2013 - Christmas Day
  • December 31st, 2013 - New Year's Eve (closed at 2pm EST)
  • January 1st, 2014 - New Year's Day

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FDA Publishes Final Guidance on Determining Whether Human Research Studies Can Be Conducted Without An IND

FDA Publishes Final Guidance on Determining Whether Human Research Studies Can Be Conducted Without an IND

FDA’s recently published guidance provides an overview of IND requirements and details specific situations in which an IND is not required. This guidance is the finalized version of a draft guidance published in October 2010. 

The guidance reviews the general requirement that human research studies be conducted under an IND when all of the following conditions exist:

  • The research involves a drug as that term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(g)(1)).
  • The research is a clinical investigation as defined in the IND regulations (21 CFR 312.3).
  • The clinical investigation is not otherwise exempt from the IND requirements in Part 312.

The guidance then describes categories of investigations exempt from IND requirements.  For exempt studies involving marketed drug products, the guidance clarifies what is meant by a drug that is “lawfully marketed” in the US.  It notes that use of the marketed version of the drug in exactly the same dosage form, dosage levels, and patient populations described in the marketed labeling for the product is not required; rather, the exemption allows for changes to the marketed product that do not increase risk. Exemptions for bioavailability/bioequivalence studies in humans are also discussed.

The guidance also describes the conditions under which radioactive and cold isotopes can be used for certain research without an IND. Specific issues concerning the application of IND regulations with respect to endogenous compounds, live organisms, cosmetics, foods, and research with noncommercial intent are also addressed.

The guidance is available online at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf

Please contact Sterling if you would like to discuss how this guidance impacts your submissions for IRB review.  

FDA Publishes Final Guidance on Mobile Medical Applications

The FDA has finalized a draft guidance originally published in July 2011 regarding mobile medical applications.

This guidance details FDA’s approach to three categories of applications:

  • FDA does not regulate mobile apps that fall outside the Federal Food, Drug, and Cosmetic Act’s definition of a medical device.
  • FDA intends to exercise enforcement discretion over mobile apps that meet the Act’s medical device definition but pose a lower risk to the public.
  • FDA will apply its regulatory oversight to “mobile medical apps,” mobile apps that meet the Act’s medical device definition and are either:
    o   intended to be used as an accessory to a regulated medical device, or
    o   intended to transform a mobile platform into a regulated medical device.

FDA aims to focus its regulatory oversight on apps that could pose a risk to patient safety if the app does not function as intended.  The guidance includes appendices providing examples of mobile apps that fall within the three categories described above. 

The guidance is available online at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf     

Please contact Sterling if you would like to discuss how this guidance impacts your submissions for IRB review.

Sterling to Attend - 2013 DIA Annual Meeting

Visit us at the 2013 DIA Annual Meeting in Boston, MA June 23-27, 2013. If you’d like to schedule a meeting, contact Kathye Richards, Director of Client Services, at 678.501.7806 / This email address is being protected from spambots. You need JavaScript enabled to view it. .

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