CancerQuest | Interview with Dr. Shakun Malik

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..

Questions and Answers

	About Dr.Shakun Malik(Time: 6 sec)
	The Role of the Office of Oncology Drug Products (OODP)(Time: 19 sec)
	Malik's Career Transition into Drug Evaluation(Time: 36 sec)
	How Malik's Experience as a Clinician Helps Her Ability to Evaluate(Time: 1 min 04 sec)
	How a Drug Receives Approval(Time: 1 min 20 sec)
	The Phases of Clinical Trials(Time: 3 min 13 sec)
	Off-Label Use of Drugs and Commpassionate Use(Time: 1 min 04 sec)
	What is the process for approval and denial of drugs?(Time: 1 min 08 sec)
	Who actually approved or denies the drug applications?(Time: 35 sec)
	How does the OODP monitor drug development?(Time: 1 min 45 sec)
	Do oncologists work at or with the OODP?(Time: 42 sec)
	How are new cancer therapies approved?(Time: 35 sec)
	Is there an accelerated drug approval track?(Time: 1 min 43 sec)
	Does the OODP oversee cancer prevention drugs?(Time: 38 sec)
	Does the OODP collaborate with other countries?(Time: 33 sec)