Biologics Approved In 2012
This article was originally published in Pharmaceutical Approvals Monthly
FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation & Research in 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins.
Allogenic cellularized scaffold product for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults, but not intended to provide root coverage
You may also be interested in...
Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.
Roche receives initial knockback for lymphoma treatment which could rival CAR-T therapies.
Parliamentary debate next week on the post-Brexit regulatory adjustments ahead for the UK medical devices industry will coincide with the opening of post-Brexit EU trade talks by the UK government. After a period of nervous calm, Brexit will be back with a bang.