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TXT Webinar Explains Indication, Usage Guidance [2642 Words] [ Price : $8.95]
CDER special assistant for labeling Iris Masucci uses a Webinar to provide detailed information on a draft guidance on the content and format of the Indications and Usage section of labeling for prescription drugs and biologics.
10/11/2018
 
 
TXT FDA $5 Million Grant to Spur Pediatric Device Development [236 Words] [ Price : $8.95]
FDA awards $5 million to the National Capital Consortium for Pediatric Device Innovation, led by Children's National Health System and University of Maryland, College Park.
10/11/2018
 
 
TXT FDA Renews Dermatologic/Ophthalmic Drugs Panel Charter [54 Words] [ Price : $8.95]
Federal Register notice: FDA renews the charter of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years.
10/11/2018
 
 
TXT FDA Clears Transseptal Solutions Access System [161 Words] [ Price : $8.95]
FDA clears a Transseptal Solutions 510(k) for the TSP Crosser Transseptal Access System, a transseptal puncture system with a built-in steering mechanism.
10/11/2018
 
 
TXT FDA Renews Charter for Antimicrobial Drugs Panel [50 Words] [ Price : $8.95]
Federal Register notice: FDA renews for two years the charter of its Antimicrobial Drugs Advisory Committee.
10/11/2018
 
 
TXT Require High-Quality Device Evidence: Blog [3045 Words] [ Price : $8.95]
Cardiologist Rita Redberg says in a Health Affairs online post that FDA should require high-quality evidence for approval of medical devices.
10/11/2018
 
 
TXT Generic Drug Approvals Set New Record [2601 Words] [ Price : $8.95]
The CDER Office of Generic Drugs sets a new record for generic drug approvals.
10/11/2018
 
 
TXT TransEnterix Gains Clearance for Smaller Surgery Instruments [84 Words] [ Price : $8.95]
FDA clears a TransEnterix 510(k) clearance for 3 millimeter diameter instruments for its Senhance System for use in microlaparoscopic surgeries.
10/11/2018
 
 
TXT Boehringer sNDA for Broader Stiolto Respimat Label OK’d [151 Words] [ Price : $8.95]
FDA approves a Boehringer Ingelheim supplemental NDA for new labeling on its Stiolto Respimat (tiotropium bromide and olodaterol) that includes data showing a meaningful reduction in chronic obstructive pulmonary disease exacerbations driven by tiotropium.
10/11/2018
 
 
TXT Safety Alert on Medtronic Cybersecurity Software Fix [114 Words] [ Price : $8.95]
FDA issues a safety alert following a Medtronic software update to address a risk caused by cybersecurity vulnerabilities associated with an Internet connection between its Carelink 2090 and Carelink Encore 29901 Programmers that are used to download software for the company’s cardiac implantable electrophysiology devices.
10/11/2018
 
 
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