FDA Approves Drug to Treat Adults with Persistent or Chronic ITP

by Pill Pals Customer Service | Sep 2, 2025 | News

ActionThe U.S. Food and Drug Administration (FDA) approved Wayrilz (rilzabrutinib) tablets to treat adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to immunoglobulins, anti-D therapy, or corticosteroids. Disease...

Efficacy Endpoints in Ophthalmologic Rare Disease Drug Development

by Pill Pals Customer Service | Sep 2, 2025 | News

On This Page Date: September 17, 2025 Time: 9:30 a.m. – 2:30 p.m. ET The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, is convening a one-day hybrid public meeting on September 17, 2025...

Drug Safety Oversight Board

by Pill Pals Customer Service | Sep 2, 2025 | News

BackgroundThe DSB, created in 2005 and mandated by law in the FDA Amendments Act of 2007, advises the CDER Center Director on the handling and communicating of important and often emerging drug safety issues. The DSB meets to provide a forum for discussion and input...

Green Vitality dba Gr33n – 710151

by Pill Pals Customer Service | Sep 2, 2025 | News

Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTERAugust 25, 2025RE: 710151Dear Privacy Compliance Officer:This letter is to advise you that the U.S. Food and Drug Administration (FDA)...

FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary

by Pill Pals Customer Service | Sep 2, 2025 | News

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2022 (PDUFA VII), authorizes FDA to assess and collect fees for prescription drug products from October 2023 through September 2027. FDA dedicates these...

Homeopathic Educational Services dba Homeopathic Family Medicine – 708635

by Pill Pals Customer Service | Sep 2, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Dana Ullman Homeopathic Educational Services dba Homeopathic Family Medicine 812Camelia Street, Suite CBerkeley, CA 94710-1418United States email@homeopathic.com Issuing Office: Center for Drug...