PPT-Emily Smith, DVM Office of New Animal Drug Evaluation (ONADE)

Division of Therapeutic Drugs for Food Animals Effectiveness Evaluation for Therapeutic Drugs for Food Animals Drugs used in the diagnosis cure mitigation treatment or prevention of a disease or condition. It is a centrally acting muscle relaxant The diversion and abuse of carisoprodol have incr eased in the last decade Licit Uses Carisoprodol is used as an adjunct to rest physical the rapy and other measures for relie f of acute painful musculoskelet The availability of crack Cocaine abuse has a long deeply rooted history in U S cocaine led to an increase in inhalation as the prefer red route of drug culture both urban and rural It is an intense and administration for many abusers In order to DFXED LYLVLRQ57347RI57347DVWURHQWHURORJ DQG57347QERUQ57347UURU 3URGXFWV LFKDUG5734757355HV5735657347VKLKDUD ULDQ573476W URQJLQ LYLVLRQ57347RI 3XOPRQDU OOHUJ 5735957347DQG573475KHXPDWRORJ 3URGXFWV 6DQG57347DUQHV LYLVLRQ57347RI573470HWDEROLVP57347DQ 6 POLICY AND PROCEDURES OFFICE OF NEW DRUGS Good Review Practice Management of Breakthrough TherapyDesignated Drugs and Biologics Table of Contents PURPOSE 1 BACKGROUND Originating Office: Office of the Center Director Effective Date: 6/8/09; 12/20/11 Page 1 of 7 OFFICE OF THE CENTER DIRECTOR Tracking of Significant Safety issues in Ma BACKGROUND OFFICE DIRECTOR MEMO Office Director Summary Review NDA 205858 Zydelig (idelalisib) On September 11, 2013, Gilead Sciences, Inc. submitted an NDA for Zydelig (idelalisib) for the proposed indication The Halo Effect is a cognitive bias in which the global evaluation of a person affects later evaluations of individual attributes of that person. The current study assessed whether a racially specific name can elicit a global evaluation that can alter perceptual judgment of certain attributes (e.g., personality traits). It was predicted that a racially specific African American name would have significantly more negative connotations than a racially specific Caucasian name, which would further be facilitated by the use of a second variable, a guise, or outward appearance (e.g., warm guise or cold guise). Results revealed a marginally significant effect for name, a significant effect for guise, and a marginally significant interaction between name and guise.. Originating Office: Office of New Drugs Effective Date: 3/9/15 Page 1 of 11 POLICY AND PROCEDURES OFFICE OF NEW DRUGS Table of Contents PURPOSE ........................................... Originating Office: Office of the Center Director Effective Date: 11/13/95; 09/28/06: 9/3/2014 Page 1 of 24 POLICY AND PROCEDURES OFFICE OF THE CENTER DIRECTOR BACKGROUND ........................ Originating Office: Office of ManagementEffective Da06/1/2015 POLICY AND PROCEDURES OFFICE OF MANAGEMENTMonitoring and obligatingUndelivered Orders (UDOs) Table of Contents PURPOSEThisMAPPclarifiesth Office of New Animal Drug Evaluation (ONADE). Division of Therapeutic Drugs for Food Animals. Effectiveness Evaluation for Therapeutic Drugs for Food Animals. . . Drugs used in the diagnosis, cure, mitigation, treatment, or prevention of a disease or condition. Originating Office: Office of New Drugs Effective Date: 5/1/98; 11/7/07; 2/26/15 Page 1 of 5 POLICY AND PROCEDURES Table of Contents BACKGROUND submitted by the applicant in response to Center for Veterinary Medicine. Regulating Animal Drugs . Protect the Public Health by ensuring . safe and effective animal drugs reach the market. unsafe and ineffective animal drugs do not reach the market. FDA/CVM Rockville, MD. Summer, 2012. An Overview of Minor Use & Minor Species Issues in the U.S.A.. 2. . What are Minor Uses & Minor Species?. Why are they important?. What are the challenges?.