Regs.gov: Food and Drug Administration

FDA Submission for Harmony Foods Magnesium Citrate Gummies

The FDA has received a submission from Harmony Foods LLC regarding their Meijer Magnesium Citrate Gummies. This notice pertains to a product submission and does not contain new regulatory requirements or guidance.

FDA Filing: New Chapter Women's 50+ Multivitamin

The FDA has received a filing from New Chapter regarding their Women's 50+ Multivitamin. This filing pertains to a product supporting immune function, cellular energy, and antioxidants for healthy aging. No specific compliance actions or deadlines are indicated in this notice.

Harmony Foods B12 Gummies Docket Information

The FDA has posted docket information for Harmony Foods LLC concerning their Free & Pure Zero Sugar B12 Gummies. This notice provides access to supporting documentation related to the product, as filed with the agency.

FDA Submission: Bio Minerals N.V. Biosil Daily Beauty Protein Vanilla

The FDA has received a submission from Bio Minerals N.V. regarding their product, Biosil Daily Beauty Protein Vanilla. This submission is part of the agency's regulatory process for new product information.

FDA - Blueroot Health Submission on Respiratory and Immune Function

The FDA has received a submission from Blueroot Health regarding their product, Vital Nutrients, Aller-C, which is intended to support healthy respiratory and immune function. This submission is part of the public record available on Regulations.gov.

FDA CDRH Variance Approval Letter for Photon GFX

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Photon GFX. This notice indicates a specific approval for a medical device variance, though no further details or documents are available for review.

FDA Complaint Document

The FDA has posted a complaint document to the Regs.gov portal on March 17, 2026. The document is available for public viewing and download via the provided link.

FDA Variance Application from Alpha-Omega Services

The FDA has received a variance application from Alpha-Omega Services, Inc. The application pertains to medical device regulations. Further details are available via the provided URL.

FDA Complaint Document

The FDA has posted a complaint document related to FDA-2026-H-2311-0001. The document is available for review on the Regs.gov platform. No further details on the nature of the complaint or its implications are provided.

FDA GRAS Notice 1288 Amendment for Steviol Glycosides

The FDA has posted an amendment to GRAS Notice 1288 concerning enzyme-modified steviol glycosides. This notice is from the manufacturer and is part of the Generally Recognized As Safe (GRAS) notification process.

FDA CDER Response Letter to Hyman, Phelps & McNamara

The FDA's Center for Drug Evaluation and Research (CDER) has posted a response letter addressed to the law firm Hyman, Phelps & McNamara, P.C. The document was made available on March 17, 2025, through the Regs.gov portal. No other details regarding the content of the response are provided.

FDA Document on Contraceptive Status Among Females 15-49

The Food and Drug Administration (FDA) has issued a document concerning contraceptive status among females aged 15-49. This notice provides information on the topic without introducing new regulatory requirements.

FDA Variance Application from J.M.W. Entertainment Group

The FDA has posted a variance application from The J.M.W. Entertainment Group, LLC. This document 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 notice.

FDA Complaint Document Details

The FDA has posted details regarding a complaint document, with the information made available on March 16, 2026. The document is related to a complaint filed with the agency.

FDA Acknowledgment Letter to J.M.W. Entertainment Group

The FDA issued an acknowledgment letter to The J.M.W. Entertainment Group, LLC, regarding a submission. This notice confirms receipt of documentation by the FDA's Center for Devices and Radiological Health (CDRH).

FDA Complaint Document Posted

The FDA has posted a complaint document related to its regulatory activities. The document was made available on March 16, 2026, and was open for public comment. No specific details about the complaint's content or the nature of the comment period are provided.

FDA Variance Application from Audio Source, Inc

The FDA has posted a variance application from Audio Source, Inc. This document is available for review on the Regs.gov platform. The application pertains to medical device regulations.

FDA Variance Amendment from J.M.W. Entertainment Group

The FDA has posted a variance amendment from J.M.W. Entertainment Group, LLC. The document was made available on March 16, 2026, via the Regs.gov portal. No further details on the amendment's content are provided.

FDA Complaint Document

The FDA has posted a complaint document related to its activities, with the comment period closing on March 16, 2026. The document is available for public review and input.

FDA Complaint Posted for Public Comment

The FDA has posted a complaint for public comment, with the comment period closing on March 16, 2026. This action allows for public input on a specific complaint filed with the agency.

FDA Guidance on Progestins as Endocrine Disruptors

The FDA has issued new guidance concerning progestins and their potential role as endocrine disruptors. This document outlines the agency's current thinking and provides information relevant to manufacturers and public health authorities.

FDA Study on Oral Contraception and HIV Risk in Africa

The FDA has published a notice regarding a study on the relationship between oral contraception and HIV risk in Africa. This notice is associated with docket number FDA-2026-P-2641-0031.

FDA Study on Contraceptives, Herpes, and HIV Risk

The FDA has posted a study concerning the relationship between contraceptives, herpes, and HIV risk. The study details are available through the agency's regulatory portal.

FDA Glucocorticoid Receptor Gene Expression Study

The FDA has posted a study concerning Glucocorticoid Receptor gene expression. This notice is for informational purposes and does not introduce new regulatory requirements.

FDA Acknowledgment Letter to Audio Source, Inc

The FDA has issued an acknowledgment letter to Audio Source, Inc. regarding a submission. This notice confirms receipt of the document by the agency.

FDA Background Material on Contraceptive Use and HIV-1 Transmission Risk

The FDA has posted background material concerning contraceptive use and the risk of HIV-1 transmission. This notice provides scientific information relevant to public health discussions and regulatory considerations.

Hormonal Contraceptive Eligibility for Women at High HIV Risk

The FDA has issued draft guidance regarding the eligibility of hormonal contraceptives for women at high risk of HIV. This guidance aims to clarify recommendations and ensure appropriate access to contraceptive methods while considering HIV prevention strategies.

FDA Progestins Classification and Pharmacology

The Food and Drug Administration (FDA) has published a document detailing the classification and pharmacology of progestins. This guidance provides information for manufacturers and pharmaceutical companies regarding these substances.

FDA Mammography Standards Quality Act Requirements Comment Request

The FDA has submitted a proposed collection of information related to Mammography Quality Standards Act requirements to the Office of Management and Budget (OMB) for review. The agency is requesting public comments on this information collection, with a deadline of April 13, 2026.

FDA Variance Application from William Moore - Public Comment

The FDA is accepting public comments on a variance application submitted by William Moore. The comment period is open until March 13. This action pertains to a specific application for a variance.

FDA Variance Application from Low Frequency Productions

The FDA is accepting comments on a variance application submitted by Low Frequency Productions. This application pertains to medical device regulations. The comment period for this application closed on March 13.

FDA Variance Approval for North Bay Productions

The FDA has issued a variance approval letter to North Bay Productions. This document, originating from the CDRH, signifies an approval related to a specific variance request.

FDA Complaint Document Details

The US Food and Drug Administration (FDA) has posted details regarding a complaint document. The document is available for review, though no specific details about its content or the nature of the complaint are provided in the notice.

FDA Approves Labeling for RLD, NDA N021411

The FDA has approved labeling for RLD (Reference Listed Drug) and NDA (New Drug Application) N021411. This notice indicates a regulatory action related to drug approval and labeling requirements.

FDA Acknowledgment Letter to Athyna Pharma

The FDA's Center for Drug Evaluation and Research (CDER) has issued an acknowledgment letter to Athyna Pharma, LLC. This notice confirms receipt of a submission from the company.

FDA Approves Labeling for RS, ANDA 202682

The U.S. Food and Drug Administration (FDA) has approved labeling for RS, as indicated by ANDA 202682. This approval was posted on March 13, 2026, and pertains to specific drug product labeling.

FDA Document - Copyrighted Content

The FDA has posted a document containing copyrighted content, identified by the docket number FDA-2026-P-2640-0004. The content itself is restricted due to copyright. This notice serves to inform the public of the document's availability and its restricted nature.

FDA Variance Approval Letter

The FDA has issued a variance approval letter to Richard Lathrop, authored by CDRH. The letter, which contains restricted personally identifiable information, has been redacted and is available for download.

FDA Acknowledgment Letter to Special FX Rentals

The FDA's Center for Devices and Radiological Health (CDRH) has issued an acknowledgment letter to Special FX Rentals. This notice confirms receipt of documentation and does not indicate approval or disapproval of any submissions.

FDA Complaint Document

The FDA has posted a complaint document related to FDA-2026-H-2387-0001. The document is authored by CTP and is available for download. This indicates a new enforcement action or investigation has been initiated.

FDA Document Details

The Food and Drug Administration (FDA) has published details for a new document on regulations.gov. This notice provides access to the document and its associated information for interested parties. Further details regarding the document's content are available via the provided URL.

FDA Complaint for Public Comment

The FDA has posted a complaint for public comment, with the comment period closing on March 13, 2026. The complaint was authored by the CTP and is available for download.

FDA Natural Family Planning Curricula Background Material

The FDA has posted background material related to Natural Family Planning curricula. This notice provides informational resources for interested parties.

FDA Complaint - Public Comment Period Closed

The FDA has posted a complaint document related to FDA-2026-H-2396-0001. The public comment period for this complaint has now closed. No specific details about the complaint's content or the agency's next steps are available in the provided information.

FDA Acknowledgment Letter to Irish Multimedia, LLC

The FDA has issued an acknowledgment letter to Irish Multimedia, LLC regarding a submission. The letter confirms receipt of the submission but provides no substantive details on its content or purpose.

FDA Proposes Pediatric Labeling Changes for ADHD Drugs

The FDA has issued a proposal to update the pediatric labeling for certain Attention Deficit Hyperactivity Disorder (ADHD) drugs. This consultation seeks public comment on the proposed changes to ensure accurate and up-to-date information for healthcare providers and patients regarding the use of these medications in children.

Strattera Oral Solution SMPC Posting

The FDA has posted the Summary of Product Characteristics (SMPC) for Strattera oral solution on March 13, 2026. This posting provides updated information regarding the drug's characteristics and usage. It is intended for informational purposes for drug manufacturers and healthcare professionals.

Draft Labeling for Atomoxetine HCL Solution

The FDA has posted draft labeling for Atomoxetine HCL Solution for public comment. This document outlines proposed changes to the drug's labeling, which will impact manufacturers and potentially healthcare providers.

FDA Complaint Document

The FDA has posted a complaint document related to enforcement actions. The document, authored by CTP, is available for review. Further details on the specific allegations and parties involved are not provided in the initial posting.

FDA Document on Ovarian Cancer Risk Factors

The FDA has released a document concerning risk factors associated with ovarian cancer. This guidance is intended for manufacturers and healthcare providers involved in the pharmaceutical and medical device sectors.