Drug categories

Question 1

FDA timelines:

Answer 1

NDA (new drug application) submission
within 60 days
decision whether: 
priority review (6mo)
standard review (10mo)
clinical supplement review (10mo)
FDA fast track: 
60days for review --> serious conditions, no alternative (trade off)

Question 2

Fast track:

Answer 2

for serious and life-threatening diseases, no available therapy, better than the available therapy, same benefit, but less toxic to available therapy. There could also be a rolling review (submission of portions)

Question 3

Accelerated approval:

Answer 3

not so much used anymore today. Established with oncology and HIV in mind. Approval based on surrogate endpoints. Usually twice the Phase 3, prove it’s efficacy twice.

Question 4

What are orphan drugs?

Answer 4

drugs for a disease or a condition that affects few people. (orphan disease) In the US lots of motivational incentives to produce orphan drugs (obesity - no lifestyle change) orphan drugs get exclusivity rights. ..

Question 5

problem with orphan drugs?

Answer 5

way too expensive, way too many. lots of production for a very small market that makes a lot of money.
Once it is on the market it can be used for other diseases - experimental field - new application for that specific indication (indication creep)

Question 6

what are generic drug products?

Answer 6

identical or bioequivalent to a brand name drug
chemically identical but less expensive
bioequivalence / pharmacokinetcs. generic version has to deliver the same amount of active ingredients into the bloodstream in the same amount of time –> proof and then release of the drug, not the whole admission process.

Question 7

How does drug patent work?

Answer 7

patent protection usually 20y
usually registered during early clinical development
drugs patent clock ticks during development phase!! –> generic companies can conduct clinical trials while the original drug is still under patent protection.

Question 8

what is ANDA?

Answer 8

abbreviated new drug application:
less costly process for generics
relies on safety and efficacy data supplied by innovator
does not include preclinical and clinical data.
approx. 3 years

Question 9

what are biosimilars?

Answer 9

biosimilars are to biologic products what generics are to drugs. BUT: generics are cheaper than biosimilars. It is experimental.

Question 10

what are over the counter drugs?

Answer 10

in the shelf: GRASE –>

generally recognised as safe and effective