FDA Policy/General

OMB Approves 9 Information Collections

Federal Register notice: FDA is publishing a list of nine information collections that have been approved by OMB. They are:

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Biosimilar User Fee Program
Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act
Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
General Licensing Provisions; Section 351(k) Biosimilar Applications
Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA
Implementation of the Drug Supply Chain Security Act -Identification of Suspect Product and Notification
Reclassification Petitions for Medical Devices

To view the notice, click here.

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