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NEW QUESTION: 1
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
A. Consult with the legal department to discuss the best course of action.
B. Review the regulatory guidelines to determine how to proceed.
C. Request a meeting with the regulatory authority to discuss the application.
D. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
Answer: C
NEW QUESTION: 2
A solution designer is using the Import Files compiled ruleset/rule template and is not that the values entered in the GUI are being saved correctly.
What file should they look in the values entered in the GUI are being saved correctly?
A. ImportFiles.rul
B. ImportFiles.cfg
C. ImportFiles.rul.res
D. ImportFiles.rul.dll.config
Answer: A
Explanation:
Explanation
When a ruleset that is not in \rrs\collection.xml or \rules\collection.xml is added to a task in FastDoc, the *.rul (.dll) and *.rul.config files are copied to the \rules folder. A reference is added to the \rules\collection.xml file.
References:
https://www.ibm.com/support/knowledgecenter/en/SSZRWV_9.0.0/com.ibm.dc.admin.doc/dcfdc045.htm
NEW QUESTION: 3
In which of the following colors do the unposted local changes appear?
A. Red
B. Green
C. Purple
D. Blue
Answer: C
NEW QUESTION: 4
Refer to the exhibit.
A network engineer must configure a WLAN on a Cisco IOS-XE controller to support corporate devices (using VLAN 30) and BYOD (using VLAN 40) on the same secure SSID. The security team has built an ISE deployment to be used for VLAN assignment and to restrict access based on policy and posture compliance.
Given the existing WLAN configuration, which configuration change must be made?
A. Add aaa-override
B. Remove nac
C. remove ip dhcp required
D. Add mac-filtering default
Answer: A
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