Recent FDA Action

FDA Panel Seeks Tougher Antibiotic Labels – WSJ Nov 2015

we-were-listened-to-and-heard edited Nov 2016

Announcement of FDA Meeting:

The public advisory committee of the Food and Drug Administration (FDA) announces a public meeting to discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.  The most commonly known of these drugs include Cipro, Levaquin, and Avelox.  The hearing is scheduled for November 5, 2015 from 8am to 6pm in Maryland.

This is a joint meeting of the Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) and the Drug Safety and Risk Management Advisory Committee.

This is a link to the materials to read prior to the meeting:

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/ucm467380.htm

Here is a link to the information on the meeting:

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm465275.htm

Here is a document with links to the meeting’s webcast schedule:

FDA Webcast

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s