FDA Forms Form FDA 3926 — Individual Patient Expanded Access: Investigational New Drug Application (IND) Form 2579: Report of Assembly of a Diagnostic X-Ray System Form FDA 482d: Request for FSVP Records Form FDA 2301: Transmittal of Periodic Reports and Promotional Material for New Animal Drugs Form 4003: FDA Inspection Records Request Form FDA 483a: Foreign Supplier Verification Program (FSVP) Observations Form FDA 1572 Form FDA 1571 - Instructions Form FDA 1571 Notice of FDA Action Form 3674: Certification of Compliance Form 3654: Standards Data Report for 510(k)s Form 3514: CDRH Submission Cover Sheet Form 3500A Instructions for Completing Medwatch Form Form 3500A: MedWatch Mandatory Reporting Form Form 3455: Disclosure of Financial Interest and Arrangements of Clinical Investigators Form 3454: Certification of Financial Interest and Arrangements of Clinical Investigators Form 3419: Medical Device Reporting - Annual User Facility Report Form 2891: Registration of Device Establishment Form 2567: Transmittal of Labels and Circulars Form 2253 Instructions Form 2253: Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics Form 766: Importer Application to Recondition Products Form 484: Receipt for Samples Form 483: Inspectional Observations Form 482 Attachment: Resources for FDA Regulated Businesses Form 482c: Notice of Inspection - Request for Records Form 482b: Request for Information Form 482a: Demand for Records Form 482: Notice of Inspection Form 463a: Affidavit Certificate of Exportability (Section 802) Certificate of Exportability (Section 801(e)) Certificate to Foreign Government SPECIAL REPORTS Top 10 Recent FDA & DEA Developments — And What's Next in 2024 FDA Update: Recent Enforcement Blockbusters The Food and Drug Omnibus Reform Act of 2022 (FDORA): New FDA Authorities for Enforcement, Clinical Trials, Medical Devices, and Advertising and Promotion Top 10 FDA & DEA Developments of 2022 — And Predictions for 2023 Trends in FDA Enforcement: An Update on Agency Policy, Civil Settlements, Consent Decrees and Criminal Prosecutions The FDA’s Proposed Quality Management System Rule: New Responsibilities and Opportunities for Medical Device Companies Top 10 FDA & DEA Developments of 2021 — And Predictions for 2022 Top 10 Latest FDA & DEA Developments — And A Look Ahead to 2021 FDA's Use of Inspections and Other Regulatory Oversight Tools During COVID-19 and Beyond: Welcome to the New Normal (Updated Edition) FDA Enforcement Update: Recent Trends in Civil Settlements, Consent Decrees and Criminal Prosecutions Using Real-World Evidence in Clinical Trials: What Clinical Research Professionals and Product Sponsors Need To Know New Labeling Requirements for GMO/Bioengineered Foods: The National Bioengineered Food Disclosure Standard Nine Tips To Help You Pass Your Next FDA Inspection What To Do When the FDA Comes Knocking: A Guide to Surviving FDA Inspections for Small Businesses 2019’s Top Ten FDA/DEA Developments and Predictions for 2020 FDA Guidance on Product Communications: New Possibilities for Value-Based Marketing New, Faster Pathways to Market for Medical Devices Then and Now: Food and Beverage Regulatory Enforcement 9 Ways To Ace Your FDA Inspection The Revised Common Rule: What You Need To Know JUDICIAL OPINIONS People of the State of California by Orange and Santa Clara Counties v. Purdue Pharma L.P. et al Merck & Co. v. U.S. Department of Health and Human Services, No. 19-5222 (D.C. Cir. June 16, 2020) Wyeth v. Levine, 555 U.S. 555 (2009) Washington Legal Foundation v. Henney, 128 F. Supp. 2d 11 (D.D.C. 2000) Washington Legal Foundation v. Friedman, 36 F. Supp. 2d 16 (D.D.C. 1999) United States v. Universal Management Services Inc., 191 F.3d 750 (6th Cir. 1999) United States v. Park, 421 U.S. 658 (1975) United States v. Odessa Union Warehouse Co-op, 833 F.2d 172 (9th Cir. 1987) United States v. Lane Labs-USA Inc., 427 F.3d 219 (3d Cir. 2005) United States v. Jamieson-McKames Pharmaceuticals Inc., 651 F.2d 532 (8th Cir. 1981) United States v. Gel Spice Co., Inc., 773 F.2d 427 (2nd Cir. 1985) Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) United States v. Dotterweich, 320 U.S. 277 (1943) Medtronic Inc. v. Lohr, 518 U.S. 470 (1996) Kordel v. United States, 335 U.S. 345 (1948) Heckler v. Chaney, 470 U.S. 821 (1985) Estee Lauder Inc. v. United States, 727 F. Supp. 1 (D.D.C. 1989) United States v. Rx Depot, 438 F.3d 1052 (10th Cir. 2006) INTERACTIVE TOOLS 510(k) Substantial Equivalence Decision-Making Tool Reporting Adverse Events in Medical Device Clinical Trials