Recently Posted Guidance Documents

Drugs

• 11/6/2018  Hypertension: Developing Fixed-Dose Combination Drugs for Treatment Guidance for Industry
• 11/1/2018   Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment

Food 

• 11/2/2018  Draft Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics
• 11/1/2018  Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls

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