FDA Policy/General

OMB Approves 23 FDA Information Collections

Federal Register notice: FDA has announced that 23 information collections have been approved by OMB. They are:

Blood Establishment Registration and Product Listing for Manufacturers of Blood and Blood Products and Licensed Devices
Current Good Manufacturing Practice: Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals
Irradiation in the Production, Processing, and Handling of Food State Enforcement Notifications
Veterinary Feed Directive
Record Retention Requirements for the Soy Protein/Coronary Heart Disease Health Claim
Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements
Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Survey of Drug Product Manufacturing, Processing, and Packing Facilities
Current Good Manufacturing Practices for Blood and Related Regulations for Blood Components; and Requirements for Donor Testing, Donor Notification and ‘‘Lookback’’
New Animal Drugs for Investigational Use
Regulations Under the Federal Import Milk Act
Medical Device Reporting
New Plant Varieties Intended for Food Use
Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Oper-ating by Centrifugal or Filtration Separation Principle
Prescription Drug Advertisements
Animal Food Labeling; Declaration of Certifiable Color Additives
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Food Service Facility Types
Food and Cosmetic Export Certificates
National Agriculture and Food Defense Strategy Survey
Medical Product Communications That are Consistent With the Food and Drug Administration Required Labeling — Questions and Answers
Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities Questions and Answers
Study of Disclosures to Health Care Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug
Medical Conference Attendees’ Observations About Prescription Drug Promotion

To view the notice, click here.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome