Which of the following pieces of legislation established procedures for drug applications as well as investigational drugs?
Kefauver-Harris Amendment
Durham-Humphrey Amendment
Omnibus Budget Reconciliation Act
Combat Methamphetamine Epidemic Act
Kefauver-Harris Amendment
Rationale: The Kefauver-Harris Amendment established procedures for drug applications as well as investigational drugs. It introduced a requirement for manufacturers to provide proof of effectiveness and safety of drugs before approval, required drug advertising to disclose side effects, and stopped inexpensive generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications.
You might also like to view...
Which one of the following statements made by a patient's family member would cause the EMT to suspect that a patient is suffering from hypovolemic shock?
A) "He has had a rash for the past three days." B) "He cannot stop throwing up." C) "He has been taking an antibiotic for a chest cold." D) "He got up this morning and was having a hard time breathing."
An individual's beliefs about how others he cares about will view the behavior in question describes?
A) Vulnerability B) Culture C) Attitude D) Resignation
Which of the following is the correct DEA number for “Dr. Karen A. Mabry,” who formerly was “Dr. Karen Smith” when she requested her DEA number (prior to her marriage)?
a. KM 3076216 b. KS 3076216 c. AS 3076216 d. AM 3076216
All intra- and extraoral film should be stored in:
a. a lead-lined storage box. b. a disinfected drawer in the operatory. c. the original packaging until ready for use. d. the darkroom.