DRUG LAWS

Question 1

name this FDA act:

FDA gains more authority over drug marketing, labeling and direct to consumer advertising

requires post approval studies

Answer 1

FDA amendment act of 2007

Question 2

name this FDA act:

renewed FDA authority for accelerated approval of urgently needed drugs

Answer 2

FDA safety and innovation act of 2012

Question 3

law passed for control of acute pain and opioid analgesics used.

total morphine equivalent dose of a prescription for acute pain not exceeds average of 30 MED per day

Answer 3

ohio law

Question 4

name this medwatch voluntary reporting form:

voluntary reporting

Answer 4

form FDA 3500

Question 5

name this medwatch voluntary reporting form:

mandatory reporting for facilities, importers, distributors, and manufacturers

Answer 5

form FDA 3500A