FDA encourages stakeholders who are considering the use of Digital Health Technologies (DHTs) in drug development or conducting decentralized clinical trials (DCTs) to engage the agency […]

Digital health technologies (DHTs) offer many potential benefits in the development of medical products, including drugs. Advances in DHTs, including electronic sensors, computing platforms and information […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Héctor I. Gracia Collazo Recipient Title President Skyless, LLC Urb. La Rambla, Calle Castellana # […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Christopher T. Shieh Recipient Title General Manager Ultra Chem Labs Corporation 1370 Valley Vista DriveDiamond Bar, CA […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Dan Bigman Recipient Title CEO Gascó Industrial Corporation Rincón Industrial Park Calle A, Lote 3Gurabo […]

The Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), is announcing a public workshop on March 9, 2020, “FDA/FTC Workshop on […]

Summary Company Announcement Date: February 23, 2023 FDA Publish Date: February 24, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to possible microbial […]

Issued by: Guidance Issuing Office Office of Regulatory Affairs Compliance Policy Guide Guidance for FDA staff and Industry CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and […]

Image This FDA Voices is part two of FDA Commissioner Robert M. Califf’s reflection on his one-year anniversary at the agency. Part one, “Highlighting Major Issues […]