viernes, 16 de diciembre de 2016

New FDA Guidances: Drug Labeling/ DSCSA Implementation/ Electronic Informed Consent

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

1. Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format; Guidance for Industry
This guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the CLINICAL PHARMACOLOGY section of labeling that pertains to the safe and effective use of human prescription drug and biological products. 
2. Drug Supply Chain Security Act (DSCSA) Implementation: Identification of Suspect Product and Notification; Guidance for Industry
The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the
pharmaceutical distribution supply chain.
3. Use of Electronic Informed Consent - Questions and Answers; Guidance for Institutional Review Boards, Investigators, and Sponsors
This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.

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