Request for FDA Records on Roivant Sciences

Jordan Lassiter filed this request with the Food and Drug Administration of the United States of America.
Tracking #

2024-475

FDA24100128
Submitted Jan. 12, 2024
Status
Completed

From: Jordan Lassiter

Subject: Freedom of Information Act Request: Request for FDA Records on Roivant Sciences

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Jordan Lassiter
Email: Jordan@Lassiter.eu
January 10th, 2024

Food and Drug Administration
Division of Freedom of Information
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Email: fdafoia@fda.hhs.gov

ATTENTION: DETAILED REQUEST FOR RECORDS UNDER FOIA

Dear FDA FOIA Officer,

I am submitting this request under the Freedom of Information Act (5 U.S.C. § 552) for records related to Roivant Sciences. This request is prepared with precise detail to ensure thorough understanding and compliance.

Requester: Jordan Lassiter, Jordan@Lassiter.eu

Subject: Request for FDA Records on Roivant Sciences

Specific Records Requested:

Drug Approval Applications: Information on all New Drug Applications (NDAs) or Biologics License Applications (BLAs) submitted by Roivant Sciences, including status, FDA feedback, or decisions.
Clinical Trial Data: Detailed records of clinical trials conducted by or for Roivant Sciences, including trial protocols, results, and FDA observations or findings.
Adverse Event Reports: Records of adverse events reported for drugs developed by Roivant Sciences, including FDA analysis and follow-up actions.
Regulatory Correspondence: Correspondence between the FDA and Roivant Sciences regarding drug approvals, regulatory compliance, and safety inquiries.
Inspection and Audit Reports: FDA inspection and audit reports of Roivant Sciences’ facilities, including compliance status and any violations noted.
Legal Basis and Rationale:

Public Interest & Transparency: Information about Roivant Sciences is essential for public knowledge regarding pharmaceutical development and regulatory compliance.
Accountability: These records are crucial for understanding FDA oversight and the safety and efficacy of pharmaceutical products.
Fees and Costs:

Fee Waiver Request: Enclosed is a Fee Waiver Request Letter, citing the public interest nature of this inquiry.
Cost Limitation: Please notify me in advance if costs are expected to exceed $200, along with an itemized cost breakdown.
Enclosures: Fee Waiver Request Letter (Fee_Waiver_Letter_copy_1.pdf).

Intended Use of Information:
This information is sought for public interest, focusing on pharmaceutical development, regulatory compliance, and public health considerations pertaining to Roivant Sciences, and is not intended for commercial use.

Acknowledgment Requested:
Kindly acknowledge this request and provide a tracking number.

I expect a complete and timely response as per the requirements of federal law under the FOIA.

Sincerely,

Jordan Lassiter

From: Food and Drug Administration

Subject: FOI Request Received

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*** This is an automated message. Please do not reply to this email. ***
Reference: FDA24100128
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.

From: Food and Drug Administration

Subject: FDA Receipt of FOI Request Control # 2024-475

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Control number: 2024-475
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail

From: Food and Drug Administration

Subject: FDA FOIA 2024-475

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Dear Requester,

I am writing in response to your request for:

Drug Approval Applications: Information on all New Drug Applications (NDAs) or Biologics License Applications (BLAs) submitted by Roivant Sciences, including status, FDA feedback, or decisions, clinical trial data, correspondence

Information on approved applications is available at:

Drug Approvals and Databases | FDA<https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases>

Biological Approvals by Year | FDA<https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year>

Please contact me if you have questions about your request. You may also contact the FDA FOIA Public Liaison for assistance at: Office of the Executive Secretariat, US Food & Drug Administration, 5630 Fishers Lane, Room 1050, Rockville, MD 20857, E-mail: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>.

Sincerely,

Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976

From: Food and Drug Administration

Subject: 2024-475

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Hi, we responded to this request. See attached.

Sarah B. Kotler, J.D.
Director, Division of Headquarters Freedom of Information

Office of Management and Enterprise Services
Office of the Commissioner
US Food & Drug Administration
301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

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