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Comments Sought on IDE Reports/Records

10/23/2009

Federal Register Notice: FDA is seeking public comments on Investigational Device Exemptions Reports and Records —21 CFR Par...

Comments Sought on Third Party Device Inspectors

10/22/2009

Federal Register Notice: FDA seeks public comment on the publication of the criteria it intends to use to accredit third parties t...

Radiological Devices Panel to Meet

10/22/2009

Federal Register Notice: FDA’s Radiological Devices Panel of the Medical Devices Advisory Committee will meet 11/17-18, from...

Prescribing Info Labeling Guidance Out

10/19/2009

Federal Register Notice: FDA is making available a guidance for industry and review staff, Labeling for Human Prescription Drug an...

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...