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  • Lorrie D. Divers, President, QRCP Solutions, Inc.

Knock, Knock


I often emphasize that the FDA website has a wealth of publicly available information related to regulatory compliance, clinical research and development, ethics and human subjects’ protection, along with many other relevant topics. Today, I’d like to open the door to just one category of these valuable resources.

The FDA wants to help people understand the regulatory requirements related to developing, evaluating, submitting and gaining approval for new medical devices, pharmaceuticals and biologics, as well as post-marketing observations of serious side effects or other safety concerns. To support this effort, they have created ‘Learn’ websites and have ‘case studies’ on specific topics.

There are three main sites with well-organized and topical information from the device division (CDRH), the drug division (CDER), and the biologics division (CBER). For CDRH and CDER, these main websites include podcasts, webinars, and links to additional resources, as well as other educational materials, some of which are available in additional languages.

CDRH: https://www.fda.gov/training/cdrhlearn/default.htm

CDER: https://www.fda.gov/training/forhealthprofessionals/default.htm

And for small businesseses in particular:

https://www.fda.gov/drugs/developmentapprovalprocess/smallbusinessassistance/ucm483822.htm

For CBER, the main website provides a comprehensive overview of resources regarding the numerous products that fall under this division and links to key topics.

CBER:

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/default.htm

CDRH and CDER provide educational material in the form of ‘case studies’ which can be especially helpful to those new to clinical research and development and to practitioners or other health professionals seeking a general overview or guidance.

  • For medical devices, for example, one topic is “The Investigational Device Exemption (IDE) Process: When is an IDE the right choice?” This and the other device related case studies can be found at:

https://www.fda.gov/Training/CourseMaterialsforEducators/NationalMedicalDeviceCurriculum/ucm404245.htm

  • There is currently only one new drug related case study, but it is a good, general overview of the process:

https://www.fda.gov/Training/ForHealthProfessionals/ucm464124.htm

  • For post-marketing concerns, there is a case study for submitting MedWatch reports. This is an important safety monitoring tool for both the FDA and manufacturers:

https://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm539664.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Today, I've highlighted only a very small portion of the information available on the FDA website. Other regulatory authorities’ websites, such as the EMA, also have very helpful resources and information. You can find some curated links on our Resources page at: https://www.qrcpsolutions.com/resources

What topics are of interest to you? Post a comment or drop me a message and I will try to open the doors to the most requested ones in the next few weeks.

Let’s start a conversation! Follow QCRP Solutions, Inc. on LinkedIn for more quality assurance, regulatory compliance and process excellence topics. Contact me at ldivers@qrcpsolutions.com to learn more about our services.

#GCPcompliance #FDA

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