FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

Guidance on Tests for DNA Markers, Mutations, Etc.

04/21/2003

Federal Register Notice: FDA is making available a draft guidance for industry entitled Multiplex Tests for Heritable DNA Markers,...

OMB OKs Notice of Participation Info

04/21/2003

Federal Register Notice: FDA’s collection of information entitled “Notice of Participation” has been approved by...

Comments Sought on Clinical Holds Guidance

04/21/2003

Comments Sought on Clinical Holds Guidance

04/21/2003

Federal Register Notice: FDA solicits comments on the collection of information contained in a guidance entitled Guidance for Indu...

Imagent Review Period Set

04/21/2003

Federal Register Notice: FDA has determined the regulatory review period for Alliance Pharmaceutical Corp.’s Imagent (perflu...

Review Period Set for Zevalin

04/21/2003

Federal Register Notice FDA has determined the regulatory review period for Zevalin (CD20 Monoclonal Antibody) is 3,363 days for t...

OMB Approves Info on Reporting

04/21/2003

Federal Register Notice: FDA’s collection of information entitled “Medical Device Reporting: Manufacturer Reporting, I...

Review Period Set for Exelon

04/21/2003

Federal Register Notice: FDA has determined the regulatory review period for Novartis’ Exelon (rivastigmine tartrate) is 3,4...

Satellite Public Meeting on Supplement GMPs

04/21/2003

Federal Register Notice: FDA will hold a public meeting (via satellite downlink) to discuss the proposed rule on current good manu...

Review Period Set for Pfizer’s Vfend

04/18/2003

Federal Register Notice: FDA has determined the regulatory review period for Pfizer’s Vfend (voriconaxole) is 2,452 days for...