Setter: A FOIA Getter

I would like to request a copy of all records received in reply to requests 2025-3590 and 2025-4643.

Requester: Brittany Trang - STAT News

I would like to request a copy of all records received in reply to requests 2025-3590 and 2025-4643. This is an updated version of a previous request where the type of requester organization was marked incorrectly.

Requester: Brittany Trang - STAT News

Memoranda (including meeting memos) and correspondence relevant to Phosphatidylserine-derived from Fish Lecithin in GRAS Notification 000643 that are not presently available on the FDA’s website.

Requester: Brinda Mahadevan - Brinda Mahadevan

We hereby request the following documentation and appreciate your support on this: FDA Establishment Inspection Report for the FDA inspection that took place 26-Aug to 6-Sep 2024 on drug manufacturing facility Rechon Life Sciences AB in Limhamm, Sweden (FEI number 3002806978).

Requester: Bridge Regulatory Affairs, LLC - Bridge Regulatory Affairs, LLC

Subject: FOIA Request for Clinical Study Protocol – C-GUARDIANS Trial, InspireMD_x000D_ To: U.S. Food and Drug Administration (FDA), Devices Program Area_x000D_ Dear FOIA Officer,_x000D_ Under the Freedom of Information Act, I respectfully request a copy of the clinical study protocol and related clinical study docu…

Requester: Brian K Ward

Any and all materials related to the Food Contact Notification No. 1066, Milligan Bio-Tech Inc., Rapeseed oil, methyl ester (CAS Reg. No. 73891-99-3), effective May 4, 2011.

Requester: Brian Head - Exponent, Inc.

I would like a copy of the FDA Registration for Cooney Provisions Inc

Requester: Brian Cooney - Cooney Provisions

All documents, communications and records relating to or concerning the Citizen Petition filed by Scorpion Capital, LLC with the FDA on or about January 14, 2025, FDA reference number: FDA-2025-P-0182-0001

Requester: Brandon Smith - Saxena White P.A.

Dear Madam or Sir,  Please help us find the review reports with 510(k) K230013 submission file.

Requester: Blue Yang - Shenzhen Ulike Smart Electroni

Full submitted materials for the authorized De Novo submissions by Dexcom Inc.:_x000D_ 1. DEN170088_x000D_ 2. DEN140038_x000D_ 3. DEN140016_x000D_ _x000D_ Full submitted materials for the cleared 510(k) submissions by Dexcom Inc.:_x000D_ 1. K243214_x000D_ 2. K234070_x000D_ 3. K234133_x000D_ 4. K213919_x000D_ 5. K20308…

Requester: Bin Xia - Horizon Med Innovation Inc.

I have been invited to speak to the Reagan-Udall Foundation on July 23, 2025 on the topic of:_x000D_ Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population_x000D_ _x000D_ The only approved drug with fluoride I find in the Orange book is Colegate and I do not think all o…

Requester: Bill Osmunson DDS MPH - Bill Osmunson American Environ

Documents related to the Office of Orphan Products Development’s grant of an orphan drug designation for Opsynvi (macitentan and tadalafil) for the “chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II-III)” This designation is related to FDA’s ap…

Requester: Bhupesh Singh Bisht - Apotex

As per Freedom of Information, we request the Form 483s for the following 2 inspections:_x000D_ _x000D_ 1. Orchid Pharma Ltd. Inspection End Date: Feb 18, 2025, Address: Kanchipuram, India FEI: 3003747558. and _x000D_ 2. Micro Labs Limited, Inspection End Date Feb 07, 2025 Address: Bengaluru, India, FEI:3004495158._…

Requester: Bhavish Agarwal

As per Freedom of Information Action, I hereby request the Form483 for the following inspection that happened at Watson Pharma Private Limited (Teva), at their Goa, India site. The inspection was drug inspection when ended in May 2025.

Requester: Bhavish Agarwal

Please provide the following inspection-related documents in electronic PDF format: - The Form 483 for the FDA Human Drug inspection of Watson Pharma Private Limited (Teva),_x000D_ located in Goa, India, for the inspection that happened in May 2025(FEI 3005719315).

Requester: Bhavish Agarwal

Hello,_x000D_ I am seeking 483 for below information:_x000D_ Company Name: Sun Pharmaceutical Industries Ltd._x000D_ FEI Number: 3002809586_x000D_ Record Type: 483_x000D_ Inspection End Date: 13 June, 2025

Requester: Bhavarth Desai - Bhavarth Desai

We are requesting all all unredacted conflict-of-interest disclosure forms submitted to the U.S. Food and Drug Administration for every speaker or advisor at meetings, workshops, or advisory sessions related to the Postmarketing Requirement (PMR) studies commissioned following the 2012 PROP label-change petition, incl…

Requester: Bev C. Schechtman - The Doctor Patient Forum

EIR report Polyganics Holding BV 2019

Requester: Betty IJmker - Polyganics Holding BV

I am seeking any records related to the FDA approval for the first home pregnancy test, which was called The Predictor and marketed by a company called Organon. This is for a book I am writing with Margaret Crane, the inventor of the home pregnancy test and holder of the US patent for The Predictor. The test came onto…

Requester: Beth Knobel - Fordham University

I am requesting all email communications, including attachments, between myself and the following individuals: - Timothy Garman - Elena Garrison - Jim Sigg - Tom Serra These communications should cover the period from April 2019 through January 2025.

Requester: Benjamin Dedjoe - OFEMS

Subject: GEREF - NDA 020443 - Artworks

Requester: BAPI REDDY EEMANA - BPI Labs LLC

Cosette would like to request the final approved labels of Sodium Polystyrene Sulfonate Suspension from Lyne Pharmaceuticals Inc. Application number is A214912. Please provide approved labels with the package insert details as we are not able to find them on daily med.

Requester: Artiben Patel - Cosette Pharmaceuticals Inc

recall records from Telectronics, or Telectronics Pty Limited, , or Pacific Dunlop, concerning detaching or delaminating pf silicone rubber pacemaker headers.

Requester: Arthur Foster - Medical Device Design and Fab

Eugia would like to request the Cross discipline team leader review documents from the Summary Basis of Approval (SBOA) of ANDA# 214010 of Amphotericin B Liposome for Injection (50 mg / Vial) of Eugia Pharma Specialities Limited. Since this ANDA is owned by Eugia, we kindly request that no redactions be made to the in…

Requester: Apexa Chudasama - Eugia US LLC

Eugia would like to request the Summary reviews of Quality (CMC), Biopharmaceutics and Administrative of the Original ANDA documents from the Summary Basis of Approval (SBOA) of ANDA# 214010 of Amphotericin B Liposome for Injection (50 mg / Vial) of Eugia Pharma Specialities Limited. Since this ANDA is owned by Eugia,…

Requester: Apexa Chudasama - Eugia US LLC

Eugia would like to request the Summary reviews of Quality (CMC), Biopharmaceutics and Administrative of all the Supplements of ANDA documents from the Summary Basis of Approval (SBOA) of ANDA# 214010 of Amphotericin B Liposome for Injection (50 mg / Vial) of Eugia Pharma Specialities Limited. Since this ANDA is owned…

Requester: Apexa Chudasama - Eugia US LLC

Eugia would like to request the Summaries of meetings with the US FDA (including scientific or pre-submission advice) documents from the Summary Basis of Approval (SBOA) of ANDA# 214010 of Amphotericin B Liposome for Injection (50 mg / Vial) of Eugia Pharma Specialities Limited. Since this ANDA is owned by Eugia, we k…

Requester: Apexa Chudasama - Eugia US LLC

Eugia would like to request the Clinical pharmacology biopharmaceutics review(s) documents from the Summary Basis of Approval (SBOA) of ANDA# 214010 of Amphotericin B Liposome for Injection (50 mg / Vial) of Eugia Pharma Specialities Limited. Since this ANDA is owned by Eugia, we kindly request that no redactions be m…

Requester: Apexa Chudasama - Eugia US LLC

Eugia would like to request the Statistical review(s) documents from the Summary Basis of Approval (SBOA) of ANDA# 214010 of Amphotericin B Liposome for Injection (50 mg / Vial) of Eugia Pharma Specialities Limited. Since this ANDA is owned by Eugia, we kindly request that no redactions be made to the information. Ple…

Requester: Apexa Chudasama - Eugia US LLC

Eugia would like to request the Chemistry review(s) documents from the Summary Basis of Approval (SBOA) of ANDA# 214010 of Amphotericin B Liposome for Injection (50 mg / Vial) of Eugia Pharma Specialities Limited. Since this ANDA is owned by Eugia, we kindly request that no redactions be made to the information. Pleas…

Requester: Apexa Chudasama - Eugia US LLC

Eugia would like to request the Administrative document(s) and correspondence documents from the Summary Basis of Approval (SBOA) of ANDA# 214010 of Amphotericin B Liposome for Injection (50 mg / Vial) of Eugia Pharma Specialities Limited. Since this ANDA is owned by Eugia, we kindly request that no redactions be made…

Requester: Apexa Chudasama - Eugia US LLC

Form 483 for Sun Pharma Halol plant which was inspected between 1st Jun 2025 to 15 Jun 2025. FEI number 3002809586

Requester: Anubhav Agarwal - UBS India securities

Pangea has initiated the development of a generic version of Acrivastine and Pseudoephedrine Hydrochloride Capsules, 8 mg and 60 mg, referencing NDA 019806, Semprex-D (acrivastine 8 mg and pseudoephedrine hydrochloride 60 mg) approved on March 25, 1994. As the NDA 019806 for this product has been discontinued and pub…

Requester: Anthony LaViola - Pangea Pharmaceuticals, LLC

Pangea has initiated the development of a generic version of Halcinonide Topical Ointment, 0.025%. As the NDA (NDA 018125) for this product has been discontinued and publicly available information is limited. Pangea herewith submits this FOIA request to obtain FDA review documents related to NDA 018125 for Halog (Halc…

Requester: Anthony LaViola - Pangea Pharmaceuticals, LLC

Pangea has initiated the development of a generic version of Halcinonide Topical Cream, 0.025%. As the NDA (NDA 017818) for this product has been discontinued and publicly available information is limited. Pangea herewith submits this FOIA request to obtain FDA review documents related to NDA 017818 for Halog (Halcino…

Requester: Anthony LaViola - Pangea Pharmaceuticals, LLC

Copies of the U.S. Food and Drug Administration’s (FDA) chemistry and toxicology review memoranda for Food Contact Notifications (FCNs) 2406 and 2420

Requester: Anne-Catherine Barrett - Steptoe LLP

A copy of Laura Markley’s slides from her presentation on May 8, 2025, titled, “New Approach Methodologies Used in the Safety Assessment of Food Contact Substances,” given at the Genetic Toxicology Association 2025 Annual Meeting in Newark, Delaware.

Requester: Anne-Catherine Barrett - Steptoe LLP

I am requesting certified copies of the following eleven (11) documents

Requester: Annabelle Matt - History Associates, Incorporat

I am requesting certified copies of the following forty-one (41) documents from the Food & Drug Administration (“FDA”) and/or the Center for Veterinary Medicine (“CVM”) publicly available via the CVM FOIA Electronic Reading Room.

Requester: Annabelle Matt - History Associates, Incorporat

I am requesting the September 1, 2023 email written by Erika Poitevien regarding Kava. The subject is unknown, but the email begins with the following: \I hope all is well. Matt and I work with DFA's Office of Legislation. We recently received your inquiry regarding Kava and the 'FDA's categorization of Kava as a diet…

Requester: Anna Melinyshyn - Gembala, McLaughlin & Pecora C

Hologic inspections

Requester: Anna Edney - Bloomberg News

US Food and Drug Administration (FDA) conducted an inspection at Natco Pharma pharmaceutical manufacturing division located in Kothur, Hyderabad. The inspection was conducted over 10 days, from June 9-19, 2025. Please share the Form483. (FEI: 3004540906)

Requester: Ankit Kumar

USFDA inspected Sun Pharma's Halol, India facility between June 2-13 2025 . (FEI 3002809586). Please share the Form 483 for the inspection. Inspection was a Human Drugs Inspection.

Requester: Ankit Kumar

USFDA inspected Apitoria Pharma Private Limited's Patancheru Mandal, Sangareddy, India that eneded on Dec 17 2024. (FEI: 3004051616) Please share the Form 483 for this Human Drug inspection.

Requester: Ankit Kumar

facility registration for Alkuhme 2430 E Walton Blvd Auburn Hills, MI 48326 FEI 3015482062

Requester: Andrew Thomas - Alkuhme

I am requesting all releasable records on the following imports entering the US as identified from FDA import data and shipment IDs. 523-1441242-1/13/2 231-9870961-5/22/1 879-4071293-5/12-1 BYA-2502536-2/12/2 BUP-1759232-3/14/1 H77-0229508-7/13-1

Requester: Andreas FM - TPR Group

Original 0000 Summary Basis for Approval,approval letter, label(s), and clinical, nonclinical, and PKPD review summaries for BLA 103234 (Epogen/Procrit); 2003 sBLA Summary Basis of Approval, Approval letter, label, and clinical, nonclinical, and pkpd review summaries.

Requester: Andrea Loewen - Andrea Loewen

historical Imports Entry Data for human drugs (https://datadashboard.fda.gov/oii/cd/impentry-table.htm).

Requester: Anais Galdin - Dartmouth College, Tuck Busine

Phillips Pet Food Supplies (FEI 3004339400) Inspection 3/29/2024

Requester: Amy Tryon - Hill's Pet Nutrition

A copy of the EIR for Dr. Ramy Toma, Birmingham, AL. _x000D_ Inspection End date: 29Feb2024_x000D_ Study inspected mRNA-1345-P301 _x000D_ Inspector: Malcolm Nasirah _x000D_ EIR referenced in the attached document.

Requester: Amy Mucci - Moderna TX.