Gottlieb Nomination Moves Forward With a Pledge to Keep Tabs on Devices April 28, 2017 The final step in the process, a Senate floor vote, is expected in early May. Read More
Drugmakers Request Revisions to Draft Guidance on Sharing Information with Payors April 28, 2017 Allergan questioned the draft guidance’s recommendations on disclosure of HCEI to payors. Read More
FDA Posts Evaluation Summaries for More Than 100 De Novo Devices April 27, 2017 There are two options for de novo classification for novel devices of low to moderate risk. Read More
FDA Hits Aesica Over Quality Controls, Record-Keeping April 27, 2017 The inspectors found the quality management system inadequate. Read More
Bioness Receives CE Mark for the L300 Go System April 26, 2017 The device features 3D motion detection of gait events. Read More
MHRA Finds Increasing Trend of Sterility Deficiencies April 26, 2017 The three most-cited categories were pharmaceutical quality system, sterility assurance and production-related GMP issues. Read More
AdvaMed Weighs in on Pre-Request for Designation Program April 25, 2017 The guidance lays out the content and format sponsors will be expected to follow. Read More
Public Citizen Survey: Only Four Drugmakers Commit to Single-Digit Price Increases April 25, 2017 Nine companies did not support the idea, citing concerns over the U.S. healthcare system, waste and other drivers of costs. Read More
Industry Seeks a More Device-Specific Off-Label Communications Guidance April 24, 2017 The industry group also requests that FDA outline additional types of communications that are consistent with FDA-required labeling. Read More
FDA Import Alert Leaves WHO Without a Source for Birth Control API April 24, 2017 The WHO said it has not received any reports of quality issues from levonorgestrel tablets. Read More
GenMark Achieves Updated CE Mark for its ePlex Blood Culture Identification Fungal Pathogen Panel April 21, 2017 The device CE mark will include BCID gram-positive and gram-negative panels. Read More
Shire Division Asks Court to Dismiss FTC Suit over Citizen Petitions April 21, 2017 The agency claims the Shire division filed 46 meritless petitions. Read More