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The FDA recently posted guidance documents for drugs and regulated clinical investigations.
Regulated Clinical Investigations:
- 10/11/2018 – Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations
Drugs:
- 10/9/2018 – Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry
- 10/9/2018 – Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry
Courses for Clinical Research Coordinators (CRCs)
- CRC Foundations delivers basic CRC training that organizations may use for onboarding new CRCs. Included are the operational and regulatory essentials that CRCs need. It also provides a basis for learners who will later move on to the advanced course.
- CRC Advanced helps learners gain a deeper understanding of the CRC’s role by exploring key operational, leadership, regulatory, and technical elements associated with daily work.
