FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

OMB OKs Info on Tobacco Health Documents

01/23/2014

Federal Register Notice: FDA’s collection of information entitled “Tobacco Health Document Submission,” has been...

Info on IVD Labeling Sent to OMB

01/23/2014

Federal Register Notice: FDA’s proposed collection of information, “Recommended Glossary and Educational Outreach To S...

OMB OKs Info on Device Submission Feedback

01/23/2014

Federal Register Notice: FDA’s collection of information entitled “Requests for Feedback on Medical Device Submissions...

OMB Approves Info on BLA Forms

01/23/2014

Federal Register Notice: FDA’s collection of information entitled “Biologics License Application, Changes to an Approv...

FDA Sends Info on HCT/P Products to OMB

01/23/2014

Federal Register Notice: FDA’s proposed collection of information, “Human Cells, Tissues, and Cellular and Tissue-Base...

OMB OKs Info on Protection of Human Subjects

01/23/2014

Federal Register Notice: FDA’s collection of information entitled “Protection of Human Subjects: Informed Consent; Ins...

Guidance on Chronic Pulmonary Disease Tool

01/10/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Qualification of Exacerbations of Chronic ...

Guidance on Drug Development for Bacterial Pneumonia

01/10/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Community-Acquired Bacterial Pneumonia: De...

FDA to Require Pediatric Device Info

01/10/2014

Federal Register Final rule: FDA is amending the regulations on premarket approval of medical devices to include requirements rela...

FDA to Act Against Unapproved Injectables with Codeine

01/10/2014

Federal Register Notice: FDA intends to take enforcement action against unapproved and misbranded oral and injectable drug product...