ddp part 2

Question 1

 Filed by the sponsor with the FDA if
- three phases of clinical testing demonstrates
sufficient drug safety and therapeutic effectiveness

Answer 1

The New drug Application (NDA)

Question 2

The purpose of this is to gain permission to market the drug product

Answer 2

NDA

Question 3

Drug Product Labeling

Answer 3

 Description
 Clinical Pharmacology
 Indications & usage
 Contraindications
 Warnings
 Precautions
 Adverse reactions
 Drug abuse & dependence
 Overdosage
 Dosage & administration
 How supplied

Question 4

FDA respond within____ days (review clock) of receipt of an application

Answer 4

180

Question 5

• specific additional data or other requested
  material is submitted/specific conditions are met.
• pertains to development or wording of the final
  product labeling.

Answer 5

Approvable Letter

Question 6

Approval of the application permitting marketing

Answer 6

Approval Letter

Question 7

one or more deficiencies.

Answer 7

Non Approvable Letter

Question 8

Harmonizing/bringing together regulatory
requirements with long-range goal of
establishing a uniform set of standards for drug
registration within these geographic areas

Answer 8

International Conference on Harmonization
(ICH)

Question 9

International Conference on Harmonization
(ICH) focused on 3 general areas

Answer 9

A. Quality
B. safety
C. efficacy

Question 10

• stability, light stability, analytical validation, impurities
  & biotechnology

Answer 10

Quality topics

Question 11

carcinogenicity, genotoxicity, toxicokinetics,
reproduction toxicity & single & repeat dose toxicity

Answer 11

Safety topics

Question 12

population exposure, managing clinical trials, clinical
study reports, dose response, ethnic factors, good
clinical practices & geriatrics

Answer 12

Efficacy topics