Published on: 2021-19220. Final rule; technical amendment. 2021-19220. Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions; Technical Amendment
Published on: 2016-10386. Proposed rule. 2016-10386. Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Companion to Direct Final Rule
Published on: 2016-10385. Direct final rule. 2016-10385. Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products
Published on: 2015-32477. Final rule; technical amendment. 2015-32477. Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment
Published on: 2015-32246. Proposed rule. 2015-32246. Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph
Published on: 2015-16366. Final rule. 2015-16366. Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications
Published on: 2014-29522. Proposed rule. 2014-29522. Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products