Recently Posted Guidance Documents on Drugs, Clinical Trials, and Devices

Devices

9/20/2018  Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing - Guidance for Industry and Food and Drug Administration Staff

Drugs

9/19/2018 Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers

9/19/2018  Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers

9/19/2018 Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

9/19/2018  Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry

Clinical Trials

9/20/2018 Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank