Substances & reference · openFDA

Historical FDA documents

FDA press releases and papers from the agency's history, as full text. 8,858 records; openFDA updated it 2026-10-02. About this dataset

Newest records

  • For Immediate Release - November 25, 2014

    FDA News Release For Immediate Release - November 25, 2014 FDA finalizes menu and vending machine calorie labeling rules Espafiol The U.S. Food and Drug Administration today finalized two rules requiring that calorie inf…

    Press release2 pages
  • For Immediate Release - December 16, 2014

    FDA News Release For Immediate Release - December 16, 2014 FDA approves first pathogen reduction system to treat plasma The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the fir…

    Press release2 pages
  • For Immediate Release - December 23, 2014

    FDA Statement For Immediate Release - December 23, 2014 FDA Commissioner Margaret A. Hamburg's statement on FDA’s blood donor deferral policy for men who have sex with men The U.S. Food and Drug Administration is a scie…

    Press release1 pages
  • For Immediate Release - December 3, 2014

    FDA News Release For Immediate Release - December 3, 2014 FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products Espafiol The U.S. Food and Drug Adm…

    Press release3 pages
  • For Immediate Release - June 2, 2014

    FDA News Release For Immediate Release - June 2, 2014 FDA launches openFDA to provide easy access to valuable FDA public data Espafiol Today, the U.S. Food and Drug Administration launched openFDA, a new initiative desig…

    Press release2 pages
  • For Immediate Release: March 21, 2014

    FDA NEWS RELEASE For Immediate Release: March 21, 2014 FDA approves Otezla to treat psoriatic arthritis The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arth…

    Press release2 pages
  • For Immediate Release: April 17, 2014

    FDA NEWS RELEASE For Immediate Release: April 17, 2014 FDA approves Ragwitek for short ragweed pollen allergies The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered unde…

    Press release2 pages
  • For Immediate Release - August 12, 2014

    FDA News Release For Immediate Release - August 12, 2014 FDA approves donor lung preservation device that may result in more lung transplants Today, the U.S. Food and Drug Administration approved the XVIVO Perfusion Sys…

    Press release2 pages
  • For Immediate Release - November 21, 2014

    FDA News Release For Immediate Release - November 21, 2014 FDA issues additional guidance for outsourcing facilities that compound sterile human drugs Agency outlines details on registration, fees, and drug product repo…

    Press release2 pages
  • For Immediate Release - October 1, 2014

    FDA News Release For Immediate Release - October 1, 2014 The FDA takes steps to strengthen cybersecurity of medical devices To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finali…

    Press release2 pages
  • For Immediate Release - October 10, 2014

    FDA News Release For Immediate Release - October 10, 2014 FDA approves a new ultrasound imaging agent The U.S. Food and Drug Administration today approved Lumason (sulfur hexafluoride lipid microsphere) for patients who…

    Press release1 pages
  • For Immediate Release: Feb. 27, 2014

    FDA NEWS RELEASE For Immediate Release: Feb. 27, 2014 Espafiol FDA proposes updates to Nutrition Facts label on food packages The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for p…

    Press release5 pages
  • For Immediate Release - July 2, 2014

    FDA News Release For Immediate Release - July 2, 2014 Federal judge approves consent decree with New York dietary supplement maker Mira Health Products manufactured and distributed unapproved and adulterated products A…

    Press release2 pages
  • For Immediate Release - August 1, 2014

    FDA News Release For Immediate Release - August 1, 2014 FDA approves Jardiance to treat type 2 diabetes Espafiol The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to di…

    Press release2 pages
  • For Immediate Release -July 1, 2014

    FDA News Release For Immediate Release -July 1, 2014 FDA outlines expectations for human drug compounders, including registered outsourcing facilities Today, the U.S. Food and Drug Administration issued several policy d…

    Press release2 pages
  • For Immediate Release - October 10, 2014

    FDA News Release For Immediate Release - October 10, 2014 FDA approves first drug-coated angioplasty balloon catheter to treat vascular disease The U.S. Food and Drug Administration today approved the Lutonix 035 Drug C…

    Press release2 pages
  • For Immediate Release - September 25, 2014

    FDA News Release For Immediate Release - September 25, 2014 U.S. Marshals seize botanical substance kratom from southern California facility Kratom was marketed with drug claims U.S. Marshals at the request of the U.S.…

    Press release2 pages
  • For Immediate Release -June 13, 2014

    FDA News Release For Immediate Release -June 13, 2014 FDA approves Lymphoseek to help determine the extent of head and neck cancer in the body The U.S. Food and Drug Administration today approved a new use for Lymphosee…

    Press release2 pages
  • For Immediate Release: Feb. 21, 2014

    FDA NEWS RELEASE For Immediate Release: Feb. 21, 2014 En Espafiol FDA issues first orders to stop sale, distribution of tobacco products The U.S. Food and Drug Administration issued orders today to stop the further sale…

    Press release2 pages
  • FDA Statement For Immediate Release: July 17, 2014 Indictment of FedEx Corporation for Illegally Distributing…

    FDA Statement For Immediate Release: July 17, 2014 Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs Statement The U.S. Attorney for the Northern District of California today charged the FedE…

    Press release1 pages
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.