Changeflow GovPing Healthcare & Life Sciences Regs.gov: Food and Drug Administration
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Regs.gov: Food and Drug Administration

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GovPing monitors Regs.gov: Food and Drug Administration for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 355 changes logged to date.

Wednesday, March 25, 2026

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FDA Variance Approval Letter to Anthony Ritzko

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Anthony Ritzko. The letter, dated March 24, 2025, is available in both redacted and unredacted forms.

Routine Guidance Healthcare
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FDA Complaint Document Filed

The Food and Drug Administration (FDA) has filed a complaint document related to tobacco regulations. The document is available for review on the Regs.gov platform.

Routine Notice Healthcare
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FDA Complaint Document

The FDA has posted a complaint document related to its activities, identified by docket number FDA-2026-H-2424-0001. The document is available for review on the Regs.gov platform.

Routine Notice Healthcare
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FDA Variance Application from Aquatic Multimedia LLC

The FDA has posted a variance application from Aquatic Multimedia LLC. This document, submitted by CDRH, is available for review on the Regs.gov platform. No further details on the nature of the variance or its implications are provided in the available information.

Routine Guidance Pharmaceuticals
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FDA Complaint Filed

The Food and Drug Administration (FDA) has filed a complaint on March 24, 2026. The complaint is related to tobacco product regulation and was authored by CTP. Further details are available via the provided URL.

Priority review Enforcement Pharmaceuticals
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FDA Complaint Filed and Closed for Comments

The Food and Drug Administration (FDA) has filed a complaint and closed the comment period for this matter. The specific details of the complaint are not available for viewing or download within the provided document.

Routine Consultation Healthcare
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FDA Complaint Document Closed for Comments

The FDA has closed a comment period for a complaint document related to its Center for Tobacco Products (CTP). The document, identified by docket number FDA-2026-H-2885, is no longer accepting public feedback.

Routine Consultation Healthcare
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FDA Completeness Assessment Correspondence

The Food and Drug Administration (FDA) has issued a completeness assessment correspondence to Hyman, Phelps & McNamara, P.C. This document is part of the ongoing regulatory process for a submission, but no specific details about the assessment or the submission are provided in the available information.

Routine Notice Pharmaceuticals
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FDA Delays Effective Date for Spirulina Extract Color Additive

The FDA is delaying the effective date of its final order regarding the expanded use of spirulina extract as a color additive in human foods. This delay is in response to timely objections and a request for a hearing filed by Obelisk Tech Systems Inc. The agency will announce a new effective date or other administrative action later.

Priority review Rule Food Safety
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FDA Complaint Document

The FDA has posted a complaint document authored by CTP. The document was made available on March 24th and is now closed for public comments. No specific details about the complaint's content or the regulatory impact are provided.

Routine Notice Healthcare
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FDA Complaint Document

The FDA has posted a complaint document related to its Center for Tobacco Products (CTP). The document was made available on March 24, 2026, and is open for public comment.

Routine Consultation Healthcare
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FDA Complaint Document

The Food and Drug Administration (FDA) has posted a complaint document related to its activities. The document is available for review on the Regs.gov platform. No specific action is required from regulated entities at this time.

Routine Notice Healthcare
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FDA Complaint Document Details

The FDA has posted a complaint document related to its activities, identified by docket number FDA-2026-H-2617-0001. The document is available for review on the Regulations.gov portal.

Routine Notice Healthcare

Tuesday, March 24, 2026

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FDA Complaint Document

The FDA has posted a complaint document related to tobacco product regulations, authored by the Center for Tobacco Products (CTP). This document is open for public comment until March 23, 2026.

Routine Consultation Healthcare
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FDA Complaint Posted

The FDA has posted a complaint related to tobacco products, authored by CTP. The document was made available on March 23, 2026, and the comment period has closed.

Routine Notice Healthcare
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FDA Complaint Document Details

The Food and Drug Administration (FDA) has posted a complaint document related to its regulatory activities. The document is available for review, and the comment period for this specific item has closed.

Routine Notice Healthcare
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FDA Complaint Filed and Closed for Comments

The FDA has filed a complaint related to pharmaceutical products, which has now been closed for public comment. The complaint was authored by CTP and is available for review on regulations.gov.

Priority review Consultation Pharmaceuticals
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FDA Complaint Filed and Closed for Comments

The FDA has filed a complaint related to tobacco products, which is now open for public comment. The complaint was filed on March 23, 2026, and the comment period is ongoing.

Priority review Consultation Pharmaceuticals
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FDA Complaint Filed

The FDA has filed a complaint on March 23, 2026, related to tobacco product regulation. The complaint was authored by the Center for Tobacco Products (CTP). Further details on the specific allegations and parties involved are expected to be available.

Priority review Enforcement Pharmaceuticals
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FDA Completeness Assessment Correspondence

The FDA has posted Completeness Assessment Correspondence related to drug applications. This notice indicates that specific correspondence documents are available for review, authored by CDER.

Routine Notice Pharmaceuticals
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FDA Complaint Filed and Closed for Comments

The FDA has filed a complaint related to tobacco products, which is now open for public comment. The complaint was filed on March 23, 2026, and the comment period is active.

Priority review Consultation Pharmaceuticals
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FDA CDER Final Response Letter to Rising Pharma Holdings

The FDA's Center for Drug Evaluation and Research (CDER) has issued a final response letter to Rising Pharma Holdings, Inc. The document details the agency's final decision regarding the company's submission. Specific details of the response are contained within the letter.

Routine Enforcement Pharmaceuticals
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FDA Announces Public Hearing on CNPV Pilot Program

The FDA is announcing a public hearing on its Commissioner's National Priority Voucher (CNPV) Pilot Program, designed to expedite review times for qualifying new drug applications and biologics license applications. The agency is seeking feedback on program eligibility, selection processes, and review procedures.

Priority review Consultation Pharmaceuticals
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FDA Complaint Document

The FDA has posted a complaint document related to its regulatory activities. The document is available for review on the Regulations.gov portal. No specific compliance actions or deadlines are indicated for regulated entities.

Routine Notice Healthcare
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FDA CDER Final Response Letter to AdventaPharma DWC-LLC

The FDA's Center for Drug Evaluation and Research (CDER) has issued a final response letter to AdventaPharma DWC-LLC. This document is part of the ongoing regulatory process for drug applications and does not appear to contain new compliance obligations.

Routine Enforcement Pharmaceuticals
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FDA Completeness Assessment Correspondence

The FDA has posted Completeness Assessment Correspondence related to drug applications. This notice indicates that documents are available for review concerning the completeness of certain regulatory submissions.

Routine Notice Healthcare
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FDA CDER Response Letter to Laboflex, Inc.

The FDA's Center for Drug Evaluation and Research (CDER) has issued a response letter to Laboflex, Inc. The document is a final response, indicating a resolution or specific feedback on a matter concerning the company. No further details on the content or specific regulatory actions are available.

Routine Enforcement Pharmaceuticals
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Animal Drug User Fees Reporting - Comment Period

The FDA is seeking public comment on proposed information collection provisions related to its animal drug and animal generic drug user fee programs. The comment period is open until May 22, 2026, as required by the Paperwork Reduction Act.

Priority review Notice Pharmaceuticals
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FDA Complaint Document Posted for Comments

The FDA has posted a complaint document related to tobacco products for public comment. The document is available for review and submission of feedback.

Priority review Consultation Healthcare
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FDA Complaint Document

The FDA has posted a complaint document related to tobacco regulation, authored by CTP. This document is part of a public consultation process, with a comment period that has now closed.

Routine Consultation Healthcare
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FDA Complaint Document

The FDA has posted a complaint document related to its Center for Tobacco Products (CTP). The document was made available for public comment on March 23, 2026.

Routine Notice Healthcare
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FDA Complaint Document

The FDA has posted a complaint document authored by CTP. The document is available for download via a link provided on the Regs.gov portal. No further details on the complaint's content or its regulatory implications are provided.

Routine Notice Healthcare
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FDA Complaint Document

The FDA has posted a complaint document related to its Center for Tobacco Products (CTP). The document is available for review on Regulations.gov, though no specific details about the complaint's content are provided in the metadata.

Routine Notice Healthcare
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FDA Complaint Received

The FDA received a complaint on March 23, 2026, related to tobacco products. The complaint document is available for review, though no specific details or actions are provided within the metadata.

Routine Enforcement Healthcare
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FDA Complaint Document

The FDA has posted a complaint document related to its regulatory activities. The document is available for review via the provided URL, with an attachment labeled 'Complaint' authored by CTP.

Routine Notice Healthcare
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FDA Completeness Assessment Correspondence

The FDA has posted Completeness Assessment Correspondence related to drug applications. This notice provides information from the Center for Drug Evaluation and Research (CDER) regarding the completeness of submitted applications.

Routine Notice Healthcare

Saturday, March 21, 2026

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FDA Variance Application from Epic Pro Event Production

The FDA has posted a variance application from Epic Pro Event Production. The document is available for review on Regulations.gov, though no specific details or full text are provided in the initial listing.

Routine Guidance Healthcare
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FDA Response Letter for Docket FDA-2026-P-0529

The FDA has posted a response letter related to docket FDA-2026-P-0529. The document was authored by the Center for Veterinary Medicine (CVM) and is available for download. No other details or specific actions are indicated.

Routine Notice Pharmaceuticals
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FDA Variance Approval Letter to Kyle Cummings

The FDA has issued a variance approval letter to Kyle Cummings, as posted on March 20, 2026. The document is restricted due to personally identifiable information and was authored by CDRH.

Routine Notice Healthcare
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FDA Variance Application from Kyle Cummings

The FDA has posted a variance application submitted by Kyle Cummings. The application is from the CDRH (Center for Devices and Radiological Health) and is available for review, with a redacted version provided for download. No specific details of the variance are available in the provided text.

Routine Notice Healthcare
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FDA Variance Application from Illuminate Production Services

The FDA has posted a variance application from Illuminate Production Services. The document is available for review on Regs.gov, with the application submitted by CDRH.

Routine Notice Healthcare
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FDA Acknowledgment Letter to Life to the Full, LLC

The Food and Drug Administration (FDA) has issued an acknowledgment letter to Life to the Full, LLC. This letter confirms receipt of a submission from the company. The FDA's Center for Devices and Radiological Health (CDRH) is listed as an author.

Routine Notice Healthcare
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FDA Variance Application from Alexander Kulik

The FDA has posted a variance application submitted by Alexander Kulik. The application is from the CDRH (Center for Devices and Radiological Health) and has been redacted for personally identifiable information. The document is available for review on Regs.gov.

Routine Notice Healthcare
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FDA Variance Application from Vault Entertainment Inc.

The FDA has received a variance application from Vault Entertainment Inc. The document is a filing related to a variance request, with no downloadable content available directly in the provided feed entry. Further details are available via the provided URL.

Routine Notice Healthcare
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FDA Complaint Document

The FDA has closed a complaint document for public comment. The document is related to the Center for Tobacco Products (CTP) and is available for review on regulations.gov. No specific compliance deadlines or actions are detailed in this notice.

Routine Notice Healthcare
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FDA Variance Approval Letter to Feral Artisans

The FDA has issued a variance approval letter to Feral Artisans regarding a medical device. The document is available for download and further information can be accessed via the provided link.

Routine Guidance Healthcare
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FDA Variance Approval Letter to 3 Foot World

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to 3 Foot World. The document indicates a specific approval for a variance related to a medical device. No further details on the nature of the variance or its implications are provided in the metadata.

Routine Guidance Medical Devices
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FDA Acknowledgment Letter to Mykyta Sukhenko

The Food and Drug Administration (FDA) has posted an acknowledgment letter sent to Mykyta Sukhenko regarding a submission. The letter, authored by the Center for Devices and Radiological Health (CDRH), indicates a formal receipt of information or documentation.

Routine Notice Healthcare
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FDA Variance Approval Letter for Alexander Kulik

The FDA has issued a variance approval letter to Alexander Kulik, as posted on March 20, 2026. The letter, issued by the Center for Devices and Radiological Health (CDRH), pertains to a specific variance request.

Routine Guidance Healthcare
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FDA Variance Application from Matthew Lewis

The FDA has posted a variance application submitted by Matthew Lewis, with redacted information available for download. This application is related to medical device regulations and was submitted through CDRH.

Routine Notice Healthcare

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