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On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab).

Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ONS-5010 / LYTENAVA, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration.

Vitamin D is also commonly known for its role in promoting strong bones.

In the April 8, 2015, Federal Register, FDA amended the animal drug regulations to update sponsorships of NADAs and abbreviated new animal drug applications ("ANADAs").

FDA announced that it is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications.

In the July 2, 2015, Federal Register, FDA announced it is amending the biologics regulations by removing the general safety test ("GST") requirements for biological products.

In the July 3, 2017, Federal Register, FDA amended the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs...

In the June 8, 2015, Federal Register, FDA amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments...

In the September 30, 2015, Federal Register, FDA announced the amendment of color additive regulations to provide for the safe use of mica-based pearlescent pigments...

In the November 13, 2017, and January 2, 2018, Federal Register, FDA amended the food additive regulations for food additives permitted ...

In the March 20, 2015, Federal Register, FDA issued a final rule amending the color additive regulations to provide for the expanded safe use of synthetic iron oxide as a color additive...

In the November 7, 2017, Federal Register, FDA amended the color additive regulations to provide for the safe use of calcium carbonate to color hard ...

In the July 15, 2015, Federal Register, FDA announced it is amending a regulation pertaining to canned Pacific salmon.

On June 9, FDA and EPA jointly announced the update of 2004 advice regarding What You Need to Know About Mercury in Fish and Shellfish.

The draft was released for public comment in the June 11, 2014, Federal Register.

In late February, FDA announced a new "cluster" program with the European Medicines Agency ("EMA") focusing on pharmacovigilance, or medicine safety.

Export Certificates for Food and Drug Administration Regulated Products...