FDA Webinar: Webinar Draft GFI On Rheumatoid Arthritis - Developing Drug Products For Treatment; Availability – July 25, 2013

On July 25, 2013, FDA presented a webinar on a new draft guidance entitled "Draft Guidance For Industry On Rheumatoid Arthritis - Developing Drug Products For Treatment; Availability."

 

The webinar provided an opportunity to learn about the guidance from individuals involved in its preparation. It was also intended to encourage the submission of questions or comments while the guidance is still in draft form.

 

Questions may be submitted to docket so that they can be formally processed by FDA.

 

DRAFT GFI:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM354468.pdf

 

FR NOTICE

http://www.gpo.gov/fdsys/pkg/FR-2013-05-31/pdf/2013-12922.pdf 

 

Date FR NOA: 05/31/2013

Comment Period Closes: 07/30/2013

 

CONTACTS:

Nikolay Nikolov, MD

Medical Officer

Division Of Pulmonary, Allergy, And Rheumatology Products

Center for Drug Evaluation and Research (CDER)

White Oak, Bldg 22, Room 3335

301-796-5281

nikolay.nikolov@fda.hhs.gov

Presentation Information

• Draft GFI On Rheumatoid Arthritis Webinar

Resources

• Archive of Past Webinars: http://www.fda.gov/Training/GuidanceWebinars/default.htm   

 

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