Monthly Archives: May 2011

FDA LABEL INFORMATION AVAILABLE THROUGH DAILYMED WEBSITE

DailyMed provides high quality information about marketed drugs including information about FDA labels (package inserts). Advertisements

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REQUIREMENT FOR SUBMISSION OF CERTIFICATION FORM (FDA 3674)

FDA will require applicants to include an additional certification form not mentioned during the public meeting on March 2, 2011.

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PRESENTATIONS AND TRANSCRIPT FROM FDA MEETING NOW AVAILABLE

The Food and Drug Administration (FDA) has made the materials from the March 2, 2011 public meeting available on their website.

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EDUCATIONAL SESSIONS ON FDA REGULATIONS OFFERED AT SNM ANNUAL MEETING

The Society of Nuclear Medicine will hold its Annual Meeting in San Antonio, TX, in June 2011. Educational sessions offered during the meeting will include information on FDA regulations.

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FDA HOLDS PUBLIC MEETING ON GENERIC DRUG USER FEE PROGRAM

On Tuesday, May 10, 2011, the FDA hosted a public meeting to gather stakeholder input regarding a proposed generic drug user fee program.

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