Exam (elaborations)
RAC Exam - Devices US Questions and Answers
- Course
- Institution
RAC Exam - Devices US Questions and Answers
[Show more]
Content preview
RAC Exam - Devices US Questions andAnswers
Regulations ii- iiAnswers ii-interpret iilaws iiand iidescribe iihow iithey iiwill iibe iienforced
guidance iidocument ii- iiAnswers ii-used iito iiconvey iiFDA's iicurrent iithinking iior
iienforcement iipriorities ii- iinot iilegally iibinding
Sherley iiAmendment ii- iiAnswers ii-prohibited iilabeling iimedicines iiwith iifalse iitherapeutic
iiclaims iiintended iito iidefraud iithe iipurchaser
Pure iiFood iiand iiDrug iiAct iiof ii1906 ii- iiAnswers ii-prohibited iimisbranded iiand
iiadulterated iifoods, iidrinks iiand iidrugs iifrom iientering iiinterstate iicommerce
FD&C iiAct ii- iiAnswers ii-1938 ii- iirepealed ii1906 iilaw iiand iisherley iiamendment ii-
iimanufacturers iiwere iirequired iito iiprovide iiscientific iiproof iinew iidrugs iiwere iisafe iifor
iitheir iiintended iiuse iibefore iibeing iiplaced iion iithe iimarket; iicosmetics iiand iimedical
iidevices iiregulated; iiprohibited iiadding iipoisonous iisubstances iito iifood iiunless
iiunavoidable iior iirequired iiin iiproduction; iiFDA iigiven iiauthority iito iibring iifederal iicourt
iiinjunctions, iiproduct iiseizures, iiand iicriminal iiprosecutions
Public iiHealth iiService iiAct iiof ii1944 ii- iiAnswers ii-gave iiFDA iiauthority iiover iibiological
iiproducts ii(vaccines iiand iiserums)
Durham-Humphrey iiAmendment iiof ii1951 ii- iiAnswers ii-clarified iiwhat iiconstituted iia
iiprescription iivs iiover iithe iicounter iidrug ii- iirequired ii"Caution" iistatement
Food iiAdditives iiAmendment iiof ii1958 ii- iiAnswers ii-established iicriteria iifor iifood iito iibe
iiconsidered iiadulterated, iimislabeled iior iiharmful
Kefauver-Harris iiAmendment iiof ii1962 ii- iiAnswers ii-requires iiproof iiof iisafety iiand
iiefficacy iibefore iia iidrug iican iibe iimarketed iiin iithe iiUS
Medical iiDevice iiAmendments iiof ii1976 ii- iiAnswers ii-established iithree iiclasses iiof
iimedical iidevices iibased iion iithe iinecessary iidegree iiof iicontrol iito iiensure iisafety iiand
iiefficacy, iieach iirequiring iia iidifferent iilevel iiof iiregulatory iiscrutiny; iialso iimade
iiprovisions iifor iiER&L iiand iiGMP
Orphan iiDrug iiAct iiof ii1983 ii- iiAnswers ii-provided ii7 iiyears iiof iimarket iiexclusivity iiand
iiincentives iifor iidevelopment iiof iiorphan iidrugs iifor iirare iidiseases
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller millyphilip. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $7.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
85169 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now