Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule

Annals of the New York Academy of Sciences

Volumn 1374, Issue 1, 2016, Pages 10-16

  Park, Glen D ^a   Mitchel, Jules T ^a  

^a Target Health Inc   (United States)

Author keywords

Animal Rule; efficacy; Food and Drug Administration; safety

Indexed keywords

ANTHRAX VACCINE; BOTULINUM ANTISERUM; CIPROFLOXACIN; FILGRASTIM; HYDROXOCOBALAMIN; LEVOFLOXACIN; MOXIFLOXACIN; OBILTOXAXIMAB; PEGFILGRASTIM; PYRIDOSTIGMINE; RAXIBACUMAB;

ANTHRAX; ARTICLE; BONE MARROW SUPPRESSION; BOTULISM; COST EFFECTIVENESS ANALYSIS; CYANIDE POISONING; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GAS POISONING; HUMAN; LICENSING; MEDICAL INFORMATION; NONHUMAN; PLAGUE; PNEUMONIC PLAGUE; SEPTICEMIC PLAGUE; UNITED STATES;

EID: 84983490026     PISSN: 00778923     EISSN: 17496632     Source Type: Book Series    
DOI: 10.1111/nyas.13126     Document Type: Article

References (7)

1. Electronic Code of Federal Regulations. 2016. 21 CFR § 600 cf. March 23, 2016. Accessed March 25, 2016. http://www.ecfr.gov/cgi-bin/text-idx?SID=df1ad2a6077548a239df7156665d1cfa&mc=true&tpl=/ecfrbrowse/Title21/21cfrv7_02.tpl#0.
2. Electronic Code of Federal Regulations. 2016. 21 CFR § 300 cf. March 23, 2016. Accessed March 25, 2016. http://www.ecfr.gov/cgi-bin/text-idx?SID=df1ad2a6077548a239df7156665d1cfa&mc=true&tpl=/ecfrbrowse/Title21/21cfrv5_02.tpl#0.
3. FDA. 2015. Product development under the Animal Rule. Guidance for industry. October 2015. Accessed March 25, 2016. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM399217.pdf.
4. FDA. 2016. Animal Rule information. March 22, 2016. Accessed May 8, 2016. http://www.fda.gov/emergencypreparedness/counterterrorism/medicalcountermeasures/mcmregulatoryscience/ucm391604.htm.
5. FDA. 2016. Combination products guidance documents. February 3, 2016. Accessed May 8, 2016. http://www.fda.gov/regulatoryinformation/guidances/ucm122047.htm.
6. FDA. 2007. Guidance for industry and review staff. Target product profile—a strategic development process tool. Draft guidance. March 2007. Accessed June 8, 2016. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm080593.pdf.
7. FDA. 2014. Counter-Terrorism and Emergency Coordination Staff (CTECS). About FDA. December 7, 2014. Accessed March 25, 2016. http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm320759.htm.