CompTIA
Checkpoint
ISC
HP
Dell
EC-Council
EXIN
Fortinet
ITIL®
Juniper
PMI
Microsoft
VMware
Avaya
Google
Salesforce
Amazon
Palo Alto Networks
Certiport
ISC2
All Vendors
  2. Home
  3. Exams
  4. RAPS
  5. RAC-US

Free RAC-US Exam Braindumps (page: 11)

Page 10 of 26
PDF with 100 Questions

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

  1. Allow doctors to use the product for the off-label indication.
  2. Communicate with the sales department to stop using the promotional materials.
  3. Contact the marketing department to recall the product.
  4. Request that doctors stop using the product for the off-label indication.

Answer(s): B



Which of the following is an example of an acceptable statement for an advertisement of an approved arthritis medication?

  1. "Product X is a guaranteed cure for arthritis."
  2. "Product X is effective for the treatment of arthritis."
  3. "Product X is safe for arthritis and without side effects."
  4. "Product X is effective in all patients with arthritis."

Answer(s): B



A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

  1. The ISO national member body
  2. The ISO technical committee in charge of the area
  3. The ISO Secretariat
  4. The country's regulatory authority

Answer(s): A



When applying for marketing approval of a drug for a rare disease, which requirement can be waived?

  1. Pre-clinical studies
  2. Phase I clinical trials
  3. Phase I and II clinical trials
  4. Phase III clinical trials

Answer(s): D






Post your Comments and Discuss RAPS RAC-US exam with other Community members:

RAC-US Discussions & Posts