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Human Drugs

Final Smallpox Drug Development Guide Posted

FDA issues a final guidance entitled Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.

Federal Register

2 Fentanyl Transdermal Systems Withdrawn

Federal Register notice: FDA withdraws ANDA approvals for two fentanyl transdermal systems held by Mayne Pharma Group and Actavis Laboratories.

Medical Devices

Panel Recommends Against Mercury-containing Amalgam

FDAs Immunology Devices Panel of the Medical Devices Advisory Committee recommends that FDA should require dentists to move away from using mercury-co...

Medical Devices

Cerapedics PMA Supplement OKd for Bone Graft

FDA approves a Cerapedics PMA supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures in patients wi...

Medical Devices

CDRH Patient and Caregiver Connection Program

CDRH sets up a Patient and Caregiver Connection program to obtain feedback from these stakeholders on their experiences living with a condition or usi...

Medical Devices

Contact Lens for Pediatric Myopia Slowing Approved

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 General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 11/15/2019.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Proposal to Withdraw 4 NDAs

Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required...

Federal Register

OTC Drugs Panel Charter Renewal

Federal Register notice: FDA announces the renewal of the Nonprescription Drugs Advisory Committee for an additional two years.