RT Book, Section
A1 Dill, Jennifer L.
A1 A. Kapp, Daniel
A2 Malone, Patrick M.
A2 Witt, Benjamin A.
A2 Malone, Meghan J.
A2 Peterson, David M.
SR Print(0)
ID 1190462143
T1 Regulatory Affairs and Pharmaceutical Industry
T2 Drug Information: A Guide for Pharmacists, 7e
YR 2022
FD 2022
PB McGraw Hill
PP New York, NY
SN 9781260460308
LK accesspharmacy.mhmedical.com/content.aspx?aid=1190462143
RD 2023/01/31
AB Learning  ObjectivesAfter  completing  this  chapter,  the  reader  will  be  able  to:Compare  and  contrast  the  missions  of  the  Department  of  Health  and  Human  Services  (DHHS),  the  Food  and  Drug  Administration  (FDA),  and  Center  for  Drug  Evaluation  and  Research  (CDER).Describe  the  methods  the  FDA  uses  to  communicate  important  safety  information.Describe  the  role  of  the  CDER  Division  of  Drug  Information  (DDI).List  the  main  services  provided  by  the  CDER  DDI.Categorize  the  different  clinical  and  regulatory  resources  provided  by  the  FDA.Identify  the  FDA  and  DDI  resources  for  small  business  and  the  pharmaceutical  industry.Discuss  student  and  professional  opportunities  within  the  FDA  and  the  pharmaceutical  industry.Describe  how  health  care  professionals  (HCPs)  are  regulated  in  the  pharmaceutical  industry.Determine  acceptable  interactions  between  pharmaceutical  companies  and  practitioners.Explain  the  importance  of  collecting  adverse  event  and  product  complaint  information.