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, …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 “ …
[8-13-2025] FDA continues to advise consumers not to purchase or use the Green Lumber Natural Fuel For Men product. FDA laboratory analysis confirmed that additional versions of the Green Lumber product sold by Green Lumber Holdings LLC contain tadalafil. …
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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 “ …
