Recently Posted Guidance Documents on Drugs and Devices

Drugs

• 10/16/2018  Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements Guidance for Industry
• 10/15/2018 Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry
• 10/15/2018 Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry
• 10/15/2018  Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry

Devices

• 10/18/2018 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff