Promulgate Regulations, Pursuant to Section 505 (21 U.S.C. 355), of the Federal Food, Drug and Cosmetic Act ("FDCA") to Exempt From Compliance, Modify or Waive the Requirements for Compliance Under Sections 503(B), 505(D)(1) and (D)(4) for OTC Monographs, and Specifically Exempts Asthma and Anaphylaxis Medications From OTC Non-Prescription Drug Status

 
Docket ID: FDA-2013-P-0711
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Promulgate Regulations, Pursuant to Section 505 (21 U.S.C. 355), of the Federal Food, Drug and Cosmetic Act ("FDCA") to Exempt From Compliance, Modify or Waive Requirements
Keyword(s): cder, 2013-4520, FDA-2012-N-0171, allergy, asthma, mothers, asthmatics, pursuant , 21 C.F.R., AANMA, promulgate, 21 U.S.C. 355, technologies, innovative, nonprescription, NIH, open
Legacy ID: 2013-4520
Type: Nonrulemaking
Docket Status: OPEN
Center: CDER
Docket Item Code: P
 

Primary Documents

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Comment Period Closed
Other
Posted: 05/16/2014
ID: FDA-2013-P-0711-0005
Comment Period Closed
Other
Posted: 06/19/2013
ID: FDA-2013-P-0711-0002
Other
Posted: 06/19/2013
ID: FDA-2013-P-0711-0001

Supporting Documents

 
No documents available.

Comments

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5
Comments Received*
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