Gardasil gets FDA Designated Priority Review
WHITEHOUSE STATION, N.J. The Food and Drug Administration recently accepted Merck’s Gardasil for priority review for older women, according to published reports.
Gardasil, officially called Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant, is currently indicated for females from age nine to 26 for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV.
The FDA is now placing Gardasil under designated priority review for women ranging from ages 27 through 45. Acceptance of the supplemental Biologics License application under priority review displays that the FDA will take up to 6 months to review it, rather than the usual 10 months it takes to review a new supplement.
TMH gets FDA OK for AutoSafety Injector
SHEFFIELD, United Kingdom The Food and Drug Administration has granted 510(k) clearance to The Medical House for its Compact AutoSafety Injector.
This clearance allows for the device, which is used for assisting self–administered subcutaneous injections to enter the market.
According to Ian Townsend, chairman, The Medical House: “This a key milestone achievement for TMH as it is our first ASI device to receive FDA pre-market notification which allows us to market the CASI in the US. It is also a vital approval for the project involving our global pharmaceutical partner and its commercial strategy. We are all delighted with this news and we look forward to reporting more progress for our Drug Delivery Division in due course”.
HealthPort wins top honors at Texas EHR Summit
COLUMBIA, S.C. HealthPort was named one of the top two vendors at a recent event held by the Texas Association of Community Health Center entitled the TACHC EHR Summit last month. The company was one of eight national/international electronic health record companies selected to participate.
More than 15 EHR vendors were initially identified as having a community health center appropriate software solution, but the eight finalists were selected when they incorporated CHC-specific clinical and functional elements and then demonstrated how those elements were used in a CHC setting during a web based pre-screening event.
At the summit, a representative from each vendor captured clinical details in a 15-minute, timed-staged encounter. Immediately following each demonstration, audience participants used a keypad to vote on 6 criteria, providing the vendor and attendees immediate feedback on the look, feel, and functionality of the software.
“It was an honor and privilege to have been selected to attend the TACHC EHR Summit. The strength of our CHC product suite was acknowledged by attendees, illustrating why HealthPort has achieved significant CHC marketshare over the past 20 plus years,” says Kerry de Vallette, senior vice president of solution sales for HealthPort.