Recently Posted Guidance Documents on Drugs and Devices

Drugs

11/6/2018  Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry

11/6/2018  Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry

Devices

11/5/2018 Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking - Immediately in Effect Guidance for Industry and Food and Drug Administration Staff