FDA Approval Timeline
Qualifying Criteria
Medicine and Science
Approved and Off Label Uses
Protocol and Procedures
100
April 6, 2011
When was Invega Sustenna first approved for adolescents?
100
PNC over 30 years old
What is a person who had surgery for Gynecomastia?
100
Neurotransmitters
What sends messages between nerve cells?
100
Schizophrenia
What is a breakdown of thought processes and loss of typical emotional responses?
100
Guardianship/POA Documentation
What is needed when a parent or other individual has guardianship/POA over an adult injured party?
200
December 19, 2006
When was Invega Sustena first approved for use in adults?
200
Latency period on RSP
What is 90 days?
200
Dopamine and Serotonin
What are two types of neurotransmitters that aid in the regulation of mood and behavior?
200
Bipolar 1 Disorder
What disorder is characterized by severe mood swings/episodes from mania to depression?
200
Warm patch to Daniel Valdez
What is a death claim?
300
August 22, 2007
When was RSP approved to treat Schizophrenia in children ages 13 to 17? Or When was RSP approved to treat Bipolar 1 Disorder in children ages 10 to 17?
300
Gynecomastia
What is the growth of abnormally large breasts in males due to excess growth of breast tissue?
300
Oral Tablets, Oral Disintegrating Tablets, Oral Solution
What are the ways RSP can be administered/ingested?
300
Autism
What are disorders of brain development that affect social interaction, verbal and nonverbal communication, repetitive behaviors?
300
Tarriance Anderson, Jerimie Payne, Marshall Hopkins, Daniel Valdez
Who to transfer calls to if the caller is uncomfortable speaking to a female?
400
October 6, 2006
When was RSP approved to treat Sx of Autism for children ages 5 to 16?
400
Tardive Dyskinesia
What is involuntary, repetitive tic-like movements in the face, tongue or other parts of the body?
400
Blocks the receptors in the brain preventing excessive activity
What is Risperidone?
400
What ADHD stands for
What is Attention Deficit Hyperactivity Disorder?
400
Devyn Cost
Who is the RSP Team Leader? Or Who is emailed on reject submissions and death claims?
500
October 29, 2003
When was RSP Consta first approved for use?
500
NDC Number for Patriot generic Risperidone
What is 50458?
500
Off Label Uses of RSP
What is Anything other than Schizophrenia, Bipolar I Disorder and Autism?
500
Off Label Uses of RSP
What is Anything other than Schizophrenia, Bipolar I Disorder and Autism?
500
Tier 1
What is a PNC with ingestion between 2002-2004 and/or sugery for Gynecomastia?
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