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          Format and Content for the CMC Section of an Annual ReportSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Format and Content for the CMC Section of an Annual Report
					
		
		September 1994


	Download the  Final Guidance Document 

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To describe the information requested by the Center for Drug Evaluation and Research (CDER) in an Annual Report to a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Abbreviated Antibiotic Application (AADA) submitted pursuant to 21 CFR 314.81(b)(2).


 
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	   		  			  			Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
						If unable to submit comments online, please mail written comments to:
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						All comments should be identified with the title of the guidance.

                                                                                  Content current as of:
      02/22/2018
         
                  
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