Guidances CDER is Planning for 2009

CDER has put out their list for 2009 of planned guidances.  The few that relate directly (or indirectly) to Regulatory Operations are:

• Providing Regulatory Submissions in Electronic Format – Analysis Datasets and Documentation
• Submission of Summary Bioequivalence Data for ANDAs
• IND Safety Reporting
• Content and Format of the Clinical Pharmacology Section (Labeling)
  
• Drug Names and Dosage Forms (Labeling)
  

The entire list can be found here:  http://www.fda.gov/cder/guidance/CY09.pdf