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                Development Resources

Development Resources

                        Advancing Real-World Evidence Program
          Antibacterial Drug Development Task Force
          BEST Resource Taxonomy
          Clinical Outcome Assessment Compendium
          Complex Innovative Trial Design Meeting Program
          Division of Pediatric and Maternal Health
          FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
          Ingredients
          Medical Imaging and Drug Development
          Rare Disease Endpoint Advancement Pilot Program
          Split Real Time Application Review (STAR)
          Surrogate Endpoint Resources for Drug and Biologic Development
          Model-Informed Drug Development Paired Meeting Program
          MIDD Paired Meeting Program Frequently Asked Questions


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          Development Resources
          Division of Pediatric and Maternal HealthDevelopment Resources Division of Pediatric and Maternal Health
  
  	
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The Division of Pediatric and Maternal Health (DPMH) is located in the Office of New Drugs.  DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and to improve pregnancy and lactation-related information in product labeling.

PREA Noncompliance Letters (*PREA Non-compliance letters and the letters from sponsors*)
	Pregnancy and Lactation Labeling Rule (PLLR)
	Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)Maternal Health

Pregnancy Registry Listing
	Maternal Health Guidance Documents
	Clinical Trials in Pregnant Women
	Post-Approval Studies in Pregnant Women
	Lactation Studies
	FDA Public Meetings of Interest
	Selected Presentations
	PublicationsPediatrics

Pediatric Summaries, Full Reviews, Statistics & Pediatric Exclusivity Determinations
	Pediatric Labeling Changes Information Database (PREA/BPCA/Pediatric Rule)
	Pediatric Guidance(s)
	Off-Patent Studies under BPCA
	Adult-Related Conditions That Qualify for a Waiver Because They Rarely or Never Occur in Pediatrics
	Statutes and Regulations
	Pediatric Review Committee (PeRC)
	Historical References**Contact DPMH**

Food and Drug Administration
Center for Drug Evaluation and Research
Office of New Drugs
10903 New Hampshire Avenue
Silver Spring, MD 20993
Main Line: 301-796-2200   
Fax: 301-796-9744

Office and Division Contact Information (PDF - 77KB)

Resources

Pediatric Advisory Committee
	Pediatric Counter-Terrorism Measures
	Pediatric Therapeutics
	Children's Health - Consumer Updates
	National Institute of Child Health and Human Development

                                                                                  Content current as of:
      04/24/2023
              
              
Regulated Product(s)
		 DrugsHealth Topic(s)
			  Children's Health
			    			       			    			       Breast Feeding
			       			    			       PregnancyDevelopment Resources

          
                        Advancing Real-World Evidence Program
          Antibacterial Drug Development Task Force
          BEST Resource Taxonomy
          Clinical Outcome Assessment Compendium
          Complex Innovative Trial Design Meeting Program
          Division of Pediatric and Maternal Health
          FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria
          Ingredients
          Medical Imaging and Drug Development
          Rare Disease Endpoint Advancement Pilot Program
          Split Real Time Application Review (STAR)
          Surrogate Endpoint Resources for Drug and Biologic Development
          Model-Informed Drug Development Paired Meeting Program
          MIDD Paired Meeting Program Frequently Asked Questions


                        Cancer Drugs
          Drug Interactions & Labeling
          Labeling Information | Drug Products
 
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