Federal Register notice: FDA withdraws ANDA approvals for two fentanyl transdermal systems held by Mayne Pharma Group and Actavis Laboratories.
FDAs Immunology Devices Panel of the Medical Devices Advisory Committee recommends that FDA should require dentists to move away from using mercury-co...
FDA approves a Cerapedics PMA supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures in patients wi...
CDRH sets up a Patient and Caregiver Connection program to obtain feedback from these stakeholders on their experiences living with a condition or usi...
FDA approves CooperVisions MiSight, the first contact lens indicated to slow the progression of myopia in children between the ages of eight and 12 ye...
FDA Review posts the Federal Register notices for the week ending 11/15/2019.
Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required...