What are the possible side effects (results of trials used to assess safety)? Table 4 and Table 5 summarize adverse reactions and laboratory abnormalities in the […]

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review […]

The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant […]

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food […]

Delivery Method: VIA UPS Reference #: 320-24-33 Product: Drugs Recipient: Recipient Name Mr. Tae Woo Anh Recipient Title Chief Executive Officer C&T Dream Co., Ltd. 60 […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Ricardo Cardona Recipient Title President Master Paints & Chemicals Corp. PMB 240, 425 Carr. 693 […]

Delivery Method: Via Email Reference #: 320-24-32 Product: Drugs Recipient: Recipient Name Mr. Rajeev Nannapaneni Recipient Title Vice Chairman and CEO Natco Pharma Limited Natco House […]