U.S. Food and Drug Administration Press Releases

• Published on August 23, 2025 - 02:10 GMT

  

  Blue Bell Ice Cream Issues Allergy Alert on Undeclared Almond, Walnut, and Pecan in Moo-llennium Crunch Ice Cream Packaged in a ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on August 23, 2025 - 02:10 GMT

  

  Beaver Street Fisheries, LLC Recalls Great Value Frozen Raw Shrimp Because of Possible Health Risk

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on August 22, 2025 - 17:30 GMT

  

  FDA Office of Hematology Oncology Products Reorganizes, Renamed Office of Oncologic Diseases

  November 5, 2019—The U.S. Food and Drug Administration’s office responsible for reviewing applications for new and existing cancer therapies has reorganized and been renamed as part of modernization plans approved in September 2019. The Center for Drug …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 22, 2025 - 17:30 GMT

  

  Division of Oncology 2 (DO2)

  The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: Thoracic Head & neck, Neuro-oncology Rare cancers, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 22, 2025 - 17:15 GMT

  

  FDA Begins Real-Time Reporting of Adverse Event Data

  For Immediate Release: August 22, 2025 Today, the U.S. Food and Drug Administration began daily publication of adverse event data from the FDA  Adverse Event Reporting System (FAERS). This represents a significant step forward in modernizing the agency’s …

  Distribution channels: Food & Beverage Industry
• Published on August 22, 2025 - 14:21 GMT

  

  Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee ...

  Public | Virtual Rescheduled On This Page Date: June 28, 2021 Time: 2:00 p.m. - 4:00 p.m. ET Description The Food and Drug Administration (FDA or the Agency) is announcing an annual public meeting and opportunity for public comment on “Financial …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 21, 2025 - 20:03 GMT

  

  Southwind Foods, LLC Recalls Frozen Shrimp Because of Possible Health Risk

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on August 20, 2025 - 14:45 GMT

  

  Advancing Generic Drug Development: Translating Science to Approval 2025 - 10/07/2025

  On This Page Date: October 7 - 8, 2025 Day1: Tue, Oct 07 9:00 a.m. - 04:00 p.m. ET Day2: Wed, Oct 08 9:00 a.m. - 03:00 p.m. ET This free, virtual workshop will be hosted on Microsoft Teams. On the day of the workshop, click the “Join Event” button to join …

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• Published on August 20, 2025 - 00:53 GMT

  

  B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 19, 2025 - 15:50 GMT

  

  Boothwyn Pharmacy LLC - 710247 - 06/09/2025

  Product: Animal & Veterinary Drugs Recipient: Recipient Name Arthur J. Dustman Recipient Title Chief Operating Officer Boothwyn Pharmacy LLC 221 Gale Ln Kennett Square, PA 19348 United States adustman@boothwyn.com Issuing Office: Center for Veterinary …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 19, 2025 - 15:50 GMT

  

  Everlaan Organics, Inc. dba Maple Organics - 707956 - 08/11/2025

  Delivery Method: VIA UPS Reference #: 320-25-99 Product: Drugs Recipient: Recipient Name Ms. Rosy Atwal Recipient Title Founder and CEO Everlaan Organics, Inc. dba Maple Organics 17220 Heather Dr, Unit 106 Surrey BC V3S 8G6 Canada Issuing Office: Center …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 19, 2025 - 15:50 GMT

  

  Anhui Hanbon Daily Chemical Co., Ltd. - 708903 - 08/11/2025

  Delivery Method: VIA Electronic Mail Reference #: 320-25-100 Product: Drugs Recipient: Recipient Name Mr. Alex Li Anhui Hanbon Daily Chemical Co., Ltd. No.55 Chuangye Avenue Xinqiao International Industrial Park Huainan Shi Anhui Sheng, 232221 China …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 19, 2025 - 15:50 GMT

  

  www.usaquickmeds.com - 713312 - 08/01/2025

  Recipient: www.usaquickmeds.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 19, 2025 - 15:50 GMT

  

  FDA Rationale for Recognition Decision: Isavuconazonium sulfate

  FDA has completed their review of the rationale document titled, “Isavuconazole Breakpoints for Aspergillus fumigatus” submitted by the Clinical and Laboratory Standards Institute (CLSI) to the public docket FDA-2017-N-5925-0038 in January 2025.1 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 19, 2025 - 13:53 GMT

  

  HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply

  For Immediate Release: August 19, 2025 The U.S. Department of Health and Human Services (HHS) today issued a declaration that allows the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations (EUAs) for animal drugs to treat or …

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• Published on August 19, 2025 - 01:32 GMT

  

  Approaches to Assessment of Overall Survival in Oncology Clinical Trials

  Submit Comments by 10/20/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 18, 2025 - 23:42 GMT

  

  Middlefield Original Cheese Co-Op Recalls 100% Grass-Fed Pepper Jack Cheese and Horseradish Flavored Cheese Due to Possible ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: Food & Beverage Industry
• Published on August 18, 2025 - 17:02 GMT

  

  Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data - 09/...

  On This Page Date: September 18 - 19, 2025 Day1: Thu, Sep 18 12:30 p.m. - 05:00 p.m. ET Day2: Fri, Sep 19 12:30 p.m. - 04:00 p.m. ET On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 18, 2025 - 13:32 GMT

  

  Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

  Submit Comments by 10/20/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 18, 2025 - 11:54 GMT

  

  Drug Trials Snapshots: ENFLONSIA

  HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

  Distribution channels: Healthcare & Pharmaceuticals Industry