FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Alimera Talking with FDA on Iluvien Labeling

[ Price : $8.95]

FDA says it is working with Alimera on Iluvien labeling and there is no need for the company to participate in an upcoming advisor...

Comments Sought on Supplement GMP Info

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on information collection provisions in FDAs CGMP regulations for dietary supplements....

Comments Sought on Tobacco Substantial Equivalence Requirements

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a proposed collection of information on exemptions from substantial equivalence req...

OMB OKs Info on Device ID

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information entitled Unique Device Identific...

OMB OKs Info on Cardiovascular Labeling

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on hypertension in...

Petition Cant Trigger FDA Enforcement Action

[ Price : $8.95]

FDA denies Eclats petition to have unapproved neostigmine methylsulfate injectable products removed from the market because petiti...

UDI Expert Crowley Retires to Join Industry

[ Price : $8.95]

CDRH patient safety senior advisor Jay Crowley retires from FDA to join regulatory consulting firm USDM Life Sciences as vice pres...

Baxters New Hemophelia Bleeding Therapy Approved

[ Price : $8.95]

FDA approves Baxters Feiba indicated for preventing or reducing the frequency of bleeding episodes in patients with hemophilia A o...

Amgen Cholesterol Treatment Meets Phase 3 Study Endpoint

[ Price : $8.95]

Amgen reports that its Phase 3 DESCARTES study of evolocumab in patients with high cholesterol met its primary endpoint of percent...

CDER Updates NDA/BLA Filing Review Procedures

[ Price : $8.95]

An updated CDER internal policy outlines procedures for identifying review issues during the filing review of all original NDAs, B...