FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

FDA Amends Animal Drugs Regs on Conditional Approval

01/21/2016

Federal Register Final rule: FDA is amending the animal drug regulations to reflect that the conditional approval of an applicatio...

FDA Submits Info on Dietary Supplement AERs to OMB

01/21/2016

Federal Register Notice: FDA’s proposed collection of information, “Adverse Event Reporting and Recordkeeping for Diet...

FDA Removes Conditional Approval for Kinavet-CA1 Animal Drug

01/21/2016

Federal Register Notice: FDA is providing notice that the conditional approval of an application for masitinib mesylate tablets, a...

Drug Products Not Withdrawn for S&E

01/21/2016

Federal Register Notice: FDA has determined that 12 drug products listed in this document were not withdrawn from sale for reasons...

Mevacor Not Withdrawn for S&E

01/21/2016

Federal Register Notice: FDA has determined that Mevacor (lovastatin) tablets, 20 mg and 40 mg, were not withdrawn from sale for r...

Guidance on Target Animal Safety Data

01/21/2016

Federal Register Notice: FDA is making available a guidance for industry entitled Target Animal Safety Data Presentation and Stati...

Guidance on Implanted Hemodialysis Devices

01/21/2016

Federal Register Notice: FDA is making available a guidance entitled Implanted Blood Access Devices for Hemodialysis. It was devel...

Guidance on Submitting Sterility Info in 510(k)s for Sterile Devices

01/21/2016

Federal Register Notice: FDA is making available a guidance entitled Submission and Review of Sterility Information in Premarket N...

Hearing Aid into Class 2

01/21/2016

Federal Register Final order: FDA is classifying the tympanic membrane contact hearing aid into Class 2 (special controls). The sp...

Panel to Discuss 2016-2017 Influenza Vaccine

01/06/2016

Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 3/4, from 8:30 a.m. to ...