FDA letter date archive

FDA Letters in 2016

Name: FDA Letters in 2016
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA approval and complete response letters issued or posted in 2016. This archive groups source-linked letters by issue or posting date so regulatory teams can review decisions and deficiency patterns over time.

CRLComplete Response Letter
Complete Response Letter Sun Pharma Advanced Research Company Limited (Dec 19, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 19, 2016
US FDA• XELPROS
CRLComplete Response Letter
Complete Response Letter Ferring Pharmaceuticals, Inc. (Nov 23, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Clinical efficacy and substantial evidence, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedNov 23, 2016
US FDA• MILPROSA
CRLComplete Response Letter
Complete Response Letter United Therapeutics Corporation (Oct 7, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedOct 7, 2016
US FDA• REMODULIN
CRLComplete Response Letter
Complete Response Letter Teva Pharmaceuticals USA (Sep 30, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 30, 2016
US FDA• CASSIPA
CRLComplete Response Letter
Complete Response Letter The Feinstein Institute for Medical Research (Sep 15, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Statistical analysis, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 15, 2016
US FDA• FLUORODOPA F18
CRLComplete Response Letter
Complete Response Letter Dr. Reddy’s Laboratories, SA (Aug 30, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedAug 30, 2016
US FDA• XEGLYZE
CRLComplete Response Letter
Complete Response Letter Ocular Therapeutix, Inc. (Jul 21, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJul 21, 2016
US FDA• DEXTENZA
CRLComplete Response Letter
Complete Response Letter Sandoz Inc. (Jun 24, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 24, 2016
US FDA• ZIEXTENZO
CRLComplete Response Letter
Complete Response Letter Salamandra, LLC (Jun 22, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 22, 2016
US FDA• EZALLOR SPRINKLE
CRLComplete Response Letter
Complete Response Letter Teva Pharmaceuticals USA (Jun 1, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 1, 2016
US FDA• ROMIDEPSIN
CRLComplete Response Letter
Complete Response Letter Teva Pharmaceuticals, Inc. (May 27, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Nonclinical evidence, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 27, 2016
US FDA• AUSTEDO
CRLComplete Response Letter
Complete Response Letter Scilex Pharmaceuticals, Inc. (May 10, 2016)
FDA's complete response letter contains source-text evidence related to Safety and adverse events, Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 10, 2016
US FDA• ZTLIDO
CRLComplete Response Letter
Complete Response Letter 3M Health Care (Infection Prevention Division) (May 6, 2016)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Chemistry, manufacturing, and controls, Bioequivalence and pharmacokinetics, Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedMay 6, 2016
US FDA• SOLUPREP S
CRLComplete Response Letter
Complete Response Letter Evofem, Inc. (Apr 28, 2016)
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, Chemistry, manufacturing, and controls, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 28, 2016
US FDA• PHEXX
CRLComplete Response Letter
Complete Response Letter Camargo Pharmaceutical Services (Apr 15, 2016)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedApr 15, 2016
US FDA• MYCAPSSA

Complete Response Letter Sun Pharma Advanced Research Company Limited (Dec 19, 2016)

Complete Response Letter Ferring Pharmaceuticals, Inc. (Nov 23, 2016)

Complete Response Letter United Therapeutics Corporation (Oct 7, 2016)

Complete Response Letter Teva Pharmaceuticals USA (Sep 30, 2016)

Complete Response Letter The Feinstein Institute for Medical Research (Sep 15, 2016)

Complete Response Letter Dr. Reddy’s Laboratories, SA (Aug 30, 2016)

Complete Response Letter Ocular Therapeutix, Inc. (Jul 21, 2016)

Complete Response Letter Sandoz Inc. (Jun 24, 2016)

Complete Response Letter Salamandra, LLC (Jun 22, 2016)

Complete Response Letter Teva Pharmaceuticals USA (Jun 1, 2016)

Complete Response Letter Teva Pharmaceuticals, Inc. (May 27, 2016)

Complete Response Letter Scilex Pharmaceuticals, Inc. (May 10, 2016)

Complete Response Letter 3M Health Care (Infection Prevention Division) (May 6, 2016)

Complete Response Letter Evofem, Inc. (Apr 28, 2016)

Complete Response Letter Camargo Pharmaceutical Services (Apr 15, 2016)