FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

Comments Extended 12 Months on Opioid Drugs REMS

10/19/2009

Federal Register Notice: FDA is reopening until 10/19/10 the comment period for the notice of public meeting published in the 4/20...

FDA Tobacco Act Deems Flavored Cigarettes Adulterated

09/25/2009

Federal Register Notice: FDA is providing notice that as of 9/22 according to the Family Smoking Prevention and Tobacco Control Ac...

Panel to Discuss BLA for Anthrax

09/25/2009

Federal Register Notice: FDA’s Anti-Infective Drugs Advisory Committee will meet 10/27, from 8 a.m. to 5 p.m. at the Hilton ...

FDA Corrects ANDA Withdrawal Notice

09/25/2009

Federal Register Notice: FDA is correcting a notice in the 2/11 Federal Register that announced the withdrawal of approval of 103 ...

Grant Awarded to Study Mammary Cancer Susceptibility

09/23/2009

Federal Register Notice: The Center for Veterinary Medicine and Office of New Animal Drugs is announcing the availability of grant...

FDA Proposes cGMPs for Combination Products

09/23/2009

Federal Register Proposed rule: FDA proposes to codify the current good manufacturing practice (cGMP) requirements applicable to c...

Guidance on Therapeutic Cancer Vaccines

09/18/2009

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Clinical Considerations for Ther...

ICH Prep Meeting Slated

09/18/2009

Federal Register Notice: FDA will hold a public meeting 10/14 entitled “Preparation for ICH meetings in St. Louis, Missouri&...

Public Workshop on Blood Establishment Software

08/28/2009

Federal Register Notice: FDA will hold a public workshop 11/4-5 entitled “Blood Establishment Computer Software: Understandi...

Workshop on Post-Approval Device Studies

08/19/2009

Federal Register Notice: FDA will hold a public workshop 9/9-10 entitled, “Methodologies for Post-Approval Studies of Medica...