For Immediate Release: March 21, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA approved Fabhalta (iptacopan) for the treatment of adults with complement 3 …
FDA develops resources – workshops, webinars, and seminars – to help generic drug manufacturers improve the quality of their abbreviated new drug application (ANDA) submissions and decrease the number of assessment cycles needed for approval. The following …
Delivery Method: UPS Product: Drugs Recipient: Recipient Name Mr. Il Chong Chung Seindni Co., Ltd. 610-304, 16, Gireum-ro Seongbuk-gu Seoul 02725 South Korea Issuing Office: Center for Drug Evaluation and Research United States Via UPS …
Image Caption Scientist processing Ebola virus disease samples at Donka Hospital in Conakry, Guinea as part of the EVIDENT project. (Credit: EVIDENT) This project has been completed, and this page is no longer being updated. For new project updates, visit …
Action The U.S. Food and Drug Administration has approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. Fabhalta is an oral capsule, taken twice daily. Recommended dosing is available in the …
Thank you for joining us for another episode of the Guidance Recap Podcast. The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. My name is Kylie Haskins, and I am the host for today’s podcast. In today’s …
For Immediate Release: March 20, 2025 Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an …
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 …
Delivery Method: VIA UNITED PARCEL SERVICE Product: Biologics Recipient: Recipient Name Habib (nmi) Torfi Recipient Title Chief Executive Officer Invitrx Therapeutics Inc. 20503 Crescent Bay Drive Lake Forest, CA 92630 United States Issuing Office: Center …
Reference #: CBER-19-02 Product: Biologics Recipient: Recipient Name G. Chris Christensen III Abington Memorial Hospital, IRC 1200 Old York Road Abington, PA 19001 United States Issuing Office: Center for Biologics Evaluation and Research 10903 New …
Delivery Method: VIA UNITED PARCEL SERVICE Reference #: 19-HFD-45-08-03 Product: Biologics Good Clinical Practice (GCP) Recipient: Recipient Name Susan P. King-Harris, DPM Susan P. King-Harris, D.P.M. 28100 Grand River Avenue Suite 301 Farmington Hills, MI …
Reference #: CBER 20-06 Product: Biologics Recipient: Recipient Title Chief Executive Officer Lattice Biologics, Ltd. 512 E Madison Avenue Suite 101 Belgrade, MT 59714 United States News@latticebiologics.com Issuing Office: Office of Compliance and …
Delivery Method: VIA UNITED PARCEL SERVICE Product: Biologics Recipient: Recipient Name Martin M. Porter Recipient Title Chief Operating Officer Re-Gen Active Lab, Inc. 2216 W. Walnut Hill Lane Irving, TX 75038 United States Issuing Office: Office of …
Delivery Method: VIA UPS Product: Biologics Recipient: Recipient Name Theodore I. Malinin, MD Recipient Title Medical Director and Co-Owner OsteoLife Biomedical I LLC 1951 NW 7th Avenue Sanibel Suite Miami, FL 33136 United States Issuing Office: Office of …
Delivery Method: VIA UNITED PARCEL SERVICE Product: Biologics Recipient: Recipient Name Mr. Christopher D. Jones Recipient Title Chief Executive Officer Smart Surgical, Inc dba Burst Biologics 3501 W. Elder St., Ste. 104 Boise, ID 83705 United States …
Delivery Method: VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED Reference #: OPBO 21-619233 Product: Biologics Recipient: Recipient Name Dr. Ching-Fong James Chuong, M.D. Recipient Title Medical Director Cooper Institute 7500 Beechnut Street, Suite #308 …
Delivery Method: Via Express Delivery and Electronic Mail Product: Biologics Recipient: Recipient Name Philip Quick Recipient Title Vice President of Operations Davati Medical Supply LLC 3121 Eagles Nest St. Suite 120 Round Rock, TX 78665 United States …
Delivery Method: VIA UNITED PARCEL SERVICE Product: Biologics Recipient: Recipient Name Eliott D. Spencer, Ph.D. Recipient Title President/Owner Utah Cord Bank LLC 8675 S Sandy Parkway, Bldg. 110 Sandy, UT 84070 United States Issuing Office: Office …
Recipient: Recipient Name Herman Cardenas Davati Medical Supply LLC 3121 Eagles Nest St., Suite 120 Round Rock, TX 78665 United States contact@davatimedical.com Issuing Office: Center for Biologics Evaluation and Research United States CBER 21-02 WARNING …
Delivery Method: VIA UNITED PARCEL SERVICE Product: Biologics Recipient: Recipient Name Jose R. Huerta Rebozo, MD, FACOG Recipient Title Chief Executive Officer Banco Vida Corp. 239 Arterial Hostos Avenue, Suite 604 Capital Center Building Torre Sur San …
