Oxacillin for Injection, USP, 10g by Sagent: Recall

[Posted 08/19/2016] AUDIENCE: Pharmacy ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent initiated this recall to the user level due to the receipt of a…

Public Workshop – Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests

The Food and Drug Administration is announcing the following public workshop entitled: “Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests”. The purpose of this workshop is to obtain feedback on two FDA draft guidances, “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases”…

Consumer Information on: VENTANA PD-L1(SP142) Assay

<!– –> <!– Page Last Updated: 08/18/2016 –> Page Last Updated: 08/18/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Consumer Information on: Edwards SAPIEN 3 Transcatheter Heart Valve

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Edwards SAPIEN 3 Transcatheter Heart…

Consumer Information on: Edwards SAPIEN XT Transcatheter Heart Valve

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Edwards SAPIEN XT Transcatheter Heart…