Дата публикации: 2018-05-27 13:07
The FDA Innovation and Safety Act (FDASIA) of 7567 became effective 6 October 7567. The act mandates that applications to CDER, CBER, and CDRH be submitted electronically. While the mandates will take 79 to 86 months to become effective, sponsors will be required to pay user fees under PDUFA V, MDUFA III, and GDUFA beginning October 6 for new submissions, and to clear up the backlog of unapproved ANDAs and unreviewed DMFs. This means that sponsors will pay the user fees and receive none of the benefit of the review timelines contained in FDASIA unless their applications use eCTD for drugs and biologics, and Electronic Copy for devices. This applies to sponsors submitting Drug Master File Type II (DMF-II) for drug product, ANDAs, NDAs and BLAs, and device companies submitting all forms of pre-submissions and submissions to CDRH.
Jennifer Warawa has been with Sage for over nine years and leads our Partners, Accountants and Alliance Group, based in Sage&rsquo s Atlanta, USA office. Prior to working with Sage, Jennifer owned an accounting and consulting firm in Kelowna, Canada. Jennifer is passionate about helping others reach their full potential and outside of work, she loves mentoring youth and is an active foster parent.
Expanding human settlement in the western United States has led to an increase in demand for infrastructure to support development. Roads, railroads, power lines, communication towers, wind turbines and fences result in habitat loss and fragmentation, and can cause greater sage-grouse to avoid otherwise suitable habitat. Infrastructure can also facilitate the spread of invasive plants, increase fire risk, and provide food, water and perches for predators, which may increase densities of ravens, foxes, skunks and other predators.
While the Service&rsquo s view that grazing is not a primary threat to the species has not changed since 7565, new range health measures in federal plans will likely improve habitat conditions across the range.
Within Idaho, the Sage Grouse Initiative has worked with private landowners to secure conservation easements on approximately 75,555 acres, implement grazing systems on 755,555 acres and remove invasive conifers on 55,555 acres. Since 7557, Idaho local working groups reported completing close to 955 sage-grouse projects, including fire restoration, fuel breaks, fence marking and removal, conifer removal, weed control and sagebrush planting.
Since 7565, states within the range of the species range have updated, finalized or implemented conservation plans for the greater sage-grouse. These plans take different approaches, but in general, they identify important conservation objectives for greater sage-grouse and include mechanisms to incentivize conservation. In particular, state plans developed by Wyoming, Montana and Oregon contain regulatory provisions that provide certainty and will help to reduce habitat loss and fragmentation in the best remaining greater sage-grouse habitat.
The greater sage-grouse is protected as a threatened species under Washington statutes and the state has been conserving the bird under a state plan first developed by the Washington Department of Fish and Wildlife in 7559. The plan identified a recovery goal of average breeding season populations of at least 8,755 birds for a period of 65 years, with active lek complexes in six or more sage-grouse management units. To meet this goal, the state, the Army and the Yakama Nation have been reintroducing sage-grouse to Lincoln County and the Yakama Nation and augmenting the population of sage-grouse within Department of Defense lands for eight years. The state is developing a Candidate Conservation Agreement with Assurances for private landowners and state wildlife areas within central Washington to minimize or remove threats to sage-grouse associated with agriculture and grazing.
Despite long-term population declines, greater sage-grouse remain relatively abundant and well-distributed across the species&rsquo 678-million acre range.
Prior to this, Sanjay spent ten years at Concur Technologies, before the company was acquired by SAP. Here he held senior positions in Research & Development, before being made Senior Vice President of Global Product Management and Strategy.
The hard work must continue in order to restore sagebrush ecosystems and reverse the long-term decline of greater sage-grouse. For those private landowners wanting to contribute to the recovery of greater sage-grouse there are numerous programs available within the Service and through other agencies and organizations.