FDA News Release Labeling change will affect all opioid pain medications and support more informed decision-making For Immediate Release: July 31, 2025 The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain …
Using its authority under Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, FDA required extended-release/long-acting (ER/LA) opioid analgesic (OA) new drug application holders to conduct epidemiologic studies to 1) quantify the serious risks …
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 …
Image By: ShaAvhrée Buckman-Garner, M.D., Ph.D., Director of Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), and Mary Thanh Hai, M.D., Acting Director of Office of New Drugs, CDER The U.S. Food and Drug Administration …
Spotlight Events & Announcements Get Started with Your Submission The Innovative Science and Technology Approaches for New Drugs (ISTAND) Program accepts submissions for qualification of types of drug development tools (DDTs) that are out of scope for …
Submission Process The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any …
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 …
Docket Number: FDA-2018-D-1873 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research This final guidance updates the previous version of the guidance, titled “Medical Device User Fee …
STN: BL 125070 Proper Name: Rh0(D) Immune Globulin Intravenous (Human) Tradename: RHOPHYLAC Manufacturer: CSL Behring AG, License #1766 Indication: RHOPHYLAC is Rh(D) Immune Globulin Intravenous (Human) indicated for: Suppression of Rhesus (Rh) …
Field Science - Laboratory Manual The Laboratory Manual of Quality Policies is a reference manual for laboratory personnel and supporting units. This manual has been prepared to meet the requirements for the laboratories’ accreditation to the International …
Image Products Containing 7-OH Can Cause Serious Harm Tempted to try products containing 7-hydroxymitragynine (also known as 7-OH) – such as tablets, gummies, drink mixes, and shots – sold online and at smoke shops and gas stations? Consider this: 7-OH …
FDA News Release Agency alerts health care professionals and consumers of 7-hydroxymitragynine risks For Immediate Release: July 29, 2025 The U.S. Food and Drug Administration today is taking a bold step to protect Americans from dangerous, illegal opioids …
The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
Recipient: www.plakini-pharma.com Malaysia 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 …
Recipient: www.mysteroidsmarket.com Israel 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 …
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-96 Product: Drugs Recipient: Recipient Name Mr. Nagaraj Ranganathan Recipient Title Chief Executive Officer (CEO) Shiva Analyticals Private Limited Plot 24D (P) and 34D KIADB Industrial Area …
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-94 Product: Drugs Recipient: Recipient Name Mr. Erik L. Kreider Kabana Skin Care LLC 685 S Arthur Ave Unit 9b Louisville, CO 80027-3141 United States Issuing Office: Center for Drug …
Recipient: www.d-pharmacy.com Singapore 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 …
Recipient: www.portmeds.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 …
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-51 Product: Drugs Recipient: Recipient Name Mr. Achal Agrawal Macsen Drugs F-261, 262, 263 Riico Industrial Area, Gudli Tehsil Mavli, Udaipur 313024 Rajasthan India Issuing Office: Center for …
