FDA Guidance Documents Update

Recently posted guidance documents:

5/16/16: Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry

5/19/16: Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment

5/27/16: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components; Guidance for Industry

5/31/16: Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry

6/1/16: FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - Draft Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards and Food and Drug Administration Staff

6/2/16: Individual Patient Expanded Access Applications: Form FDA 3926

6/2/16: Charging for Investigational Drugs Under an IND — Qs & As

6/2/16: E18 Genomic Sampling and Management of Genomic Data

6/2/16: Expanded Access to Investigational Drugs for Treatment Use — Qs & As

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