Comment Period Reopened on Medical Foods Guidance
11/14/2013
FDA Proposes Revised Procedures for New Labeling Info
11/13/2013
Info on Animal Feed Standards Sent to OMB
11/08/2013
Federal Register Notice: FDA’s proposed collection of information, “Draft Animal Feed Regulatory Program Standards,&rd...
Workshop on Sentinel Initiative
11/08/2013
Federal Register Notice: FDA will hold a public workshop 1/14/14 entitled “Sixth Annual Sentinel Initiative.” The Enge...
Panel to Discuss Spinal Devices, Wheelchairs
11/07/2013
Info on Expedited Programs Sent to OMB
11/07/2013
Guidance on Hearing Devices
11/07/2013
Federal Register Notice: FDA is making available a draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Per...
Guidance on Clinical Device Studies
11/07/2013
Federal Register Notice: FDA is making available a guidance entitled Design Considerations for Pivotal Clinical Investigations for...
Opportunity for Hearing on Withdrawal of 14 NDAs
11/06/2013
Federal Register Notice: FDA announces an opportunity to request a hearing on its proposal to withdraw approval of 14 NDAs from mu...
Moban Not Withdrawn for S&E
11/06/2013
Federal Register Notice: FDA has determined that Moban (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) and capsule...