Collection: Products
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CBER Director Response – Bluebird Bio Dispute (Lyfgenia, BLA #125788)
Regular price $69.00 USDRegular priceUnit price / per -
Certified Article – FDA PH Notification: Surgical Mesh Complications (Oct 20, 2008)
Regular price $69.00 USDRegular priceUnit price / per -
Certified Article – FDA Safety Communication: Surgical Mesh Update (Jul 13, 2011)
Regular price $69.00 USDRegular priceUnit price / per -
Certified Article – FDA's Activities: Urogynecologic Surgical Mesh (Jul 14, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
Certified Mammography Facilities in Missouri (as of January 2025)
Regular price $69.00 USDRegular priceUnit price / per -
Certified MAUDE Report – MDR (Keys 8746538/149627100, Report 3006443171-2019-00002)
Regular price $69.00 USDRegular priceUnit price / per -
Chemistry & Toxicology Memos - FCN No. 2372 (Poly((R)-3-hydroxybutyric acid-co-(R)-3-hydroxyhexanoic acid))
Regular price $69.00 USDRegular priceUnit price / per -
Chemistry Review – Hydrocortisone Sodium Succinate Injection (ANDA 214050, CIPLA LTD)
Regular price $69.00 USDRegular priceUnit price / per -
Clinical Pharmacology & Biopharmaceutics Review – Inderal (Propranolol Tablets, Wyeth, N016418)
Regular price $69.00 USDRegular priceUnit price / per -
Clinical Trial Records – NeuroStar Advanced Therapy System (K212289, predicate K193006)
Regular price $69.00 USDRegular priceUnit price / per -
Communication Records – Consensus Statement on Premature Infants & NEC (Oct 3, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
Communications – FDA & ANI Pharmaceuticals (ANDA 208607, Methylphenidate ER Tablets, Feb–Apr 2019)
Regular price $69.00 USDRegular priceUnit price / per -
Communications – Neera Tanden & Officials (Mitch Zeller, Brian King, Matthew Farrelly)
Regular price $69.00 USDRegular priceUnit price / per -
Complete Response & Clinical Review – NDA/BLA Drugs (Ataluren 2016, Bulevirtide 2022, Roxadustat 2021, Gefapixant 2023)
Regular price $69.00 USDRegular priceUnit price / per -
Contract Records Request – Contract #75F40122C00012
Regular price $69.00 USDRegular priceUnit price / per -
Correspondence – FDA & Hero Health Inc. (Device Classification, Hero Pill Dispenser, Class I since 2018)
Regular price $69.00 USDRegular priceUnit price / per -
Correspondence – FDA & Hero Health Inc. (General Inquiries, Hero Pill Dispenser)
Regular price $69.00 USDRegular priceUnit price / per -
Correspondence – Pangolin Laser Systems & Affiliates (Complaints included)
Regular price $69.00 USDRegular priceUnit price / per -
Cosmetic and Personal Care Product Recalls (2016-2024)
Regular price $69.00 USDRegular priceUnit price / per -
Cosmetic Product Ingredient Statements - Jafra Cosmetics (VCRP Submission)
Regular price $69.00 USDRegular priceUnit price / per -
Cosmetic Product Ingredient Statements - Kolmar (VCRP Submission)
Regular price $69.00 USDRegular priceUnit price / per -
CSV File - All Inspections Since September 1, 2024
Regular price $69.00 USDRegular priceUnit price / per -
CSV Files - All Inspections Since November 1, 2023
Regular price $69.00 USDRegular priceUnit price / per -
CTP Disclosures – Reviewer Summaries & Guides for STN EX0002449
Regular price $69.00 USDRegular priceUnit price / per -
CTP Organizational Charts – FDA Center for Tobacco Products
Regular price $69.00 USDRegular priceUnit price / per -
CTP PMTA Reviewer Guides – Oral Nicotine Pouches (Since 1/1/2023)
Regular price $69.00 USDRegular priceUnit price / per -
Custom FOIA Request
Regular price $149.00 USDRegular priceUnit price / per -
Cyclospora Outbreak Report - Parsley (Reference #1237)
Regular price $69.00 USDRegular priceUnit price / per -
Cyclospora Outbreak Report - Shrimp Salad (Reference #1245)
Regular price $69.00 USDRegular priceUnit price / per -
De Novo Submission – DEN200080 (Pre-Submission Communications)
Regular price $69.00 USDRegular priceUnit price / per -
De Novo Submission – KidneyIntelX.Dkd (DEN200052)
Regular price $69.00 USDRegular priceUnit price / per -
Device Documentation – Accession #02B0280 (Product Details)
Regular price $69.00 USDRegular priceUnit price / per -
DKT FDA-2016-N-1111
Regular price $69.00 USDRegular priceUnit price / per -
Documents – GF1804836 (FDA-Generated Materials)
Regular price $69.00 USDRegular priceUnit price / per -
Documents – Notice of FDA Action Entry E15-5147294-4
Regular price $69.00 USDRegular priceUnit price / per -
Dole Ohio Plant - Inspection Records & Correspondence (Listeria Outbreak)
Regular price $69.00 USDRegular priceUnit price / per