FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

FDA Adds 2 Tropical Diseases for Possible Priority Review

08/20/2015

Federal Register Final order: The FD&C Act authorizes FDA to award priority review vouchers (PRVs) to tropical disease product app...

Guidance on Tests/Labeling for Intravascular Stents

08/18/2015

Federal Register Notice: FDA is making available a guidance: Select Updates for Non-Clinical Engineering Tests and Recommended Lab...

Guidance on Drugs for Treating Gonorrhea

08/18/2015

Federal Register Notice: FDA is making available a guidance for industry: Uncomplicated Gonorrhea: Developing Drugs for Treatment....

Guidance on E-Submissions of Vaccine Safety Reports

08/18/2015

Federal Register Notice: FDA is making available a document entitled Providing Submissions in Electronic Format — Postmarket...

CDER/CBER Push 3.2 Version of E-Data Interchange Standards

08/18/2015

Federal Register Notice: CBER and CDER are announcing support for the 3.2 version of Clinical Data Interchange Standards Consortiu...

Participants Sought for MDR Malfunctions Pilot

08/18/2015

Federal Register Notice: FDA is soliciting nominations for participation in a pilot program for submitting medical device reports ...

Esophageal Device into Class 2

08/18/2015

Federal Register Final order: FDA is classifying the esophageal thermal regulation device into Class 2 (special controls). The spe...

FDA Corrects Notice on Quality Metrics Guidance

08/07/2015

Federal Register Notice: FDA is correcting a notice from the 7/28 Federal Register on a draft guidance for industry entitled Reque...

FDA Corrects Notice on Tobacco Product Applications

08/07/2015

Federal Register Notice: FDA is correcting a 7/31 Federal Register notice that reopened the period for public comment on modified ...

Guidance on Nanomaterials in Animal Food

08/05/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Use of Nanomaterials in Food for Animals. It is ...