RAPS

Question 1

Biologic post safety evaluation is started?

Answer 1

no later than 18 months by specific FDA office scientists

Question 2

According to FDA what is difference between proteins and peptides and chemically synthesized polypeptide

Answer 2

Proteins have more than 40 amino acids, peptides have 40 or fewer amino acids, Chemically synthesized polypeptide is entirely synthesized by chemical process and has fewer than 100 amino acids

Question 3

allergenic extracts (e.g., for allergy shots and tests) regulated by?

Answer 3

CBER

Question 4

blood and blood components regulated by?

Answer 4

CBER

Question 5

plasma derivatives regulated by?

Answer 5

CBER

Question 6

gene therapy products regulated by?

Answer 6

CBER

Question 7

devices and test kits regulated by ?

Answer 7

CBER

Question 8

human tissue and cellular products used in

transplantation regulated by?

Answer 8

CBER

Question 9

vaccines regulated by?

Answer 9

CBER

Question 10

therapeutic proteins regulated by?

Answer 10

CDER by regulated as BLA

Question 11

hormone protein products, e.g.,

insulin, growth hormone and pituitary hormones regulated by?

Answer 11

CDER

Question 12

Clinical investigations with an unapproved drug or

biologic must be conducted under?

Answer 12

IND

Question 13

clinical investigation categories

exempt from IND requirements?

Answer 13

There are 3
1) clinical research
involving marketed drug products;
 2) bioavailability or
bioequivalence studies in humans; and
 3) radioactive drugs
for certain research uses.

Question 14

Mandatory information to be included in the IND

Answer 14

1 - Administrative info
Previous human experience
Pre-clinical,
Investigator info and clinical protocol info

Question 15

Form 3674

Answer 15

Form 3674 is submitted in IND, as certificate for complaince pretaining to include clinical trail data in clical trail.gov.in