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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 021879Orig1s000 RISK ASSESSMENT and RISK MITIGATION REVIEW(S) Department of Health and Human Services Public Health Service Food and Drug.

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  2. Begin by entering the application number in the designated field. Ensure that you have the correct application number available, as it is crucial for processing.
  3. Fill in the subject line with the exact name of the drug being reviewed. Accuracy is essential here to avoid any errors in processing.
  4. Provide the applicant or sponsor's name in the appropriate section, ensuring that the spelling and any associated titles are correct.
  5. Indicate the review team's details as specified. This includes listing team members' names and their respective roles associated with the review.
  6. Complete the proposed Risk Evaluation and Mitigation Strategy (REMS) section by providing clear and concise information regarding all elements outlined.
  7. Review the executive summary and ensure all summarized information accurately reflects the contents of the form. Adjustments may be required to achieve clarity.
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Hilary D. Marston, M.D., M.P.H.

Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.

Teresa Buracchio, a physician and 10-year veteran of the FDA, was named Monday the acting director of the Office of Neuroscience.

Billy Dunn, head of the Office of Neuroscience at the FDA, is leaving the agency. His departure marks the end of an 18-year run at the FDA, during which he helped launch and lead neuroscience efforts.

The US Food and Drug Administration's (FDA) top neuroscience official, Billy Dunn, who oversaw the controversial approval of Biogen's Alzheimer's disease drug Aduhelm (aducanumab-avwa), is leaving the agency after an 18-year tenure.

Commissioner of Food and Drugs - Food and Drug Administration. Robert M. Califf, M.D., is Commissioner of Food and Drugs. President Joe Biden nominated Dr. Califf to head the U.S. Food and Drug Administration and Dr. Califf was sworn in on February 17, 2022.

Nick Kozauer - Director, Division of Neurology 2 - FDA | LinkedIn.

Abuse and misuse of benzodiazepines, such as taking them with alcohol, can lead to life-threatening side effects. Benzodiazepines already have a black box warning, which warns that taking benzodiazepines at the same time as opioids can lead to extreme sedation, slow and ineffective breathing, comas, and even death.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232