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 …
For Immediate Release: July 28, 2025 The U.S. Food and Drug Administration is recommending the removal of the voluntary hold for ambulatory patients who may now receive Elevidys, a Sarepta Therapeutics gene therapy for Duchenne Muscular Dystrophy (DMD). …
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 …
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 “ …
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 …
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 Summary Company …
For Immediate Release: July 25, 2025 The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The …
The content provides access to current FDA thinking, emerging scientific approaches, and real-world application strategies that generic drug manufacturers need to succeed in an increasingly complex regulatory environment. Browse courses available on demand …
The content reflects current FDA thinking, emerging guidance, and real-world regulatory experience, providing participants with the most reliable and up-to-date information available. Organizations utilizing this training demonstrate their commitment to …
The content provides essential expertise in pharmaceutical quality regulation, supply chain integrity, and manufacturing innovation – equipping professionals with the knowledge to navigate today's complex regulatory landscape and ensure patient safety …
The content provides step-by-step guidance for accurate, compliant submissions through CDER Direct. The resources combine regulatory requirements with real-world applications, featuring practical case studies and compliance frameworks that streamline your …
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 “ …
For Immediate Release: July 23, 2025 Under the leadership of the U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr. and the U.S. Department of Agriculture Secretary Brooke L. Rollins, the U.S. Food and Drug Administration and U.S …
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 …
FDA is undertaking a review of active ingredients used in a variety of over-the-counter (OTC) antiseptic rubs and wash products. Health care antiseptics are being evaluated separately from consumer antiseptics because they have different proposed use …
