Dr. Shakun Malik
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Dr. Malik works at the US Food and Drug Administration (FDA), where she is involved in the processes by which new cancer drugs get approved. In the interview, Dr. Malik discusses the steps in the approval (or rejection) process.
Interview Questions
About Dr. Shakun Malik
(Time:
0min
6sec
)
The Role of the Office of Oncology Drug Products (OODP)
(Time:
0min
19sec
)
Malik's Career Transition into Drug Evaluation
(Time:
0min
36sec
)
How Malik's Experience as a Clinician Helps Her Ability to Evaluate
(Time:
1min
4sec
)
How a Drug Receives Approval
(Time:
1min
20sec
)
The Phases of Clinical Trials
(Time:
3min
13sec
)
Off-Label Use of Drugs and Compassionate Use
(Time:
1min
4sec
)
What is the process for approval and denial of drugs?
(Time:
1min
8sec
)
The Benefits and Risks of Chemoprevention
(Time:
0min
35sec
)
How does the OODP monitor drug development?
(Time:
1min
45sec
)
Do oncologists work at or with the OODP?
(Time:
0min
42sec
)
How are new cancer therapies approved?
(Time:
0min
35sec
)
Is there an accelerated drug approval track?
(Time:
1min
43sec
)
Does the OODP oversee cancer prevention drugs?
(Time:
0min
38sec
)
Does the OODP collaborate with other countries?
(Time:
0min
33sec
)
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