eCTD Technical Conformance Guide Documentation and Resources 1.9 Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications 09/09/2024     eCTD Backbone […]

On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for […]

On May 14, 2025, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with […]

Image What Is a Recall? A recall is an action taken by a company to correct or remove from the market an FDA regulated product that […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-60 Product: Drugs Recipient: Recipient Name Mr. Zheng Liang Recipient Title General Manager Taizhou Jingshang Cosmetics Technology Co., Ltd. […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-70 Product: Drugs Recipient: Recipient Name Mr. Bernard Fraisse Recipient Title President & CEO Excelvision Fareva 32 […]

Delivery Method: VIA UPS Reference #: 320-25-57 Product: Drugs Recipient: Recipient Name Mr. Kee Pee Ho Recipient Title Managing Director BioAsia Worldwide Sdn Bhd H-G-01 & […]

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-67 Product: Drugs Recipient: Recipient Name Mr. Arvind Nanda Recipient Title Joint Managing Director Mentha & Allied […]

Delivery Method: VIA UPS Reference #: 320-25-66 Product: Drugs Recipient: Recipient Name Mr. WuXiong Wu Recipient Title General Manager Shantou S.E.Z. Baojie Industry Co., Ltd. Sihuang […]