Events singling out the Muslim community have led to young women asserting their identity through modest fashion—the hijab, abaya and burkha—driving up sales and provoking new fashion trends and questions about Muslim womanhood in India
Event Plans Include Enter-To-Win Registration/Travel to Cisco Live 2012 and “Meet the Author Sessions"
Morehead collaborates with Scientists with Stories and The Monti to bring you the best stories about science "fails."
Online Resource
Online Resource
On December 15, 2017, the Center for Women’s History at the New-York Historical Society hosted a Salon Conversation titled “Women of the Village.” A hearty crowd filled the Museum’s fourth-floor Skylight Gallery on a snowy Friday evening for a tour of Hotbed in the Joyce B. Cowin Women’s History Gallery, followed by a conversation between Scholarly...
The post Event Recap: Women of the Village with Blanche Wiesen Cook and Lara Vapnek appeared first on Behind The Scenes.
The malware spreads through side-loaded apps and gains deep level access to Android phones to extract sensitive data about banking apps.
Event through Feb 13-18 at BKC in Mumbai brought in 2,594 MoUs entailing Rs 7.94 lakh cr investments
Look on the bright side. Self-isolation can be an opportunity for self-improvement. The internet can help you learn almost anything and can connect with talented teachers in the virtual world
A postie who moves like Jagger. A bewigged Blondie clone (called Debbie Harris!). And a teacher who soars to Wuthering Heights. Event meets the UK's biggest rock 'n' roll copycats
Company: Nanu India Recruitment Co
Qualification: Bachelor of Business Administration (B.B.A)
Experience: 0 to 2
Salary: 2.00 to 5.00
location: Delhi, Mumbai City
Ref: 24820865
Summary: We have requirement for Assistant Manager - Event Operations After Lockdown.
Freshers also can apply as Trainee.
A woman's spirit is one of ability, perseverance, and courage no matter the situation or circumstance. This women's Day Viviana Mall in association with Nina Foundation is celebrating these abilities and perseverance of differently-abled women. The abilities of Women on wheelchairs.
A stand - up comedy act, a wheelchair acrobatic performance and a fashion show all by women on wheelchairs to celebrate the many abilities these women have that makes them just like us. In addition, there will be a special talk by Virali Modi and Dr. Ketna Mehta on the special occasion of Women's Day.
The event will kickstart a campaign to provide job opportunities and the required skills training to equip them with opportunities for the future by inviting organisations and institutes to make provision for these women!
When: March 7, 2019 at 5.30 pm onwards
Where: Viviana Mall, Thane
Catch up on all the latest Crime, National, International and Hatke news here. Also download the new mid-day Android and iOS apps to get latest updates
Events with extreme temperatures and humidity are occurring twice as often now as they were 40 years ago
-- Read more on ScientificAmerican.com
Image via: Aaron Chang Gallery Aaron Chang, popular recycled fashion swimwear designer and professional photographer, not to mention surfing legend, is opening a green art gallery in San Diego, February 28, 2009. Each of the pieces are printed with
Events of the past few months—in particular, the prolonged standoff in Marawi, Mindanao—have significantly increased concerns about terrorist activity in the southern Philippines, and in Southeast Asia more broadly. The shape and focus of the U.S.-Philippine alliance has already been somewhat in flux with the ascension of relatively new leadership in both countries—Rodrigo Duterte having…
The breakthrough therapy designation (BTD) program was initiated by the U.S. Food and Drug Administration (FDA) in 2012 to expedite the development of treatments for serious or life-threatening illness that demonstrate “substantial improvement” over existing therapies. The program has since become a widely supported mechanism for accelerating patient access to new drugs. As of March 2015, FDA has received a total of 293 requests for BTD. However, it has granted just 82 (28%), which indicates an ongoing lack of clarity over what exactly meets the criteria for the designation.
On April 24, the Center for Health Policy at Brookings convened a public meeting to explore the designation’s qualifying criteria and how FDA applies those criteria across therapeutic areas. Panelists used real-world and hypothetical case studies to frame the discussion, and highlighted major considerations for the application process, the FDA’s evaluation of the evidence, and the key factors for acceptance or rejection. The discussion also identified strategies to ensure that qualifying criteria are well understood. Here are the five big takeaways:
1. The BTD program is viewed positively by drug companies, researchers, advocates, and others
Across the board, participants expressed enthusiasm for the BTD program. Industry representatives noted that their experience had been extremely positive, and that the increased cooperation with and guidance from FDA were very helpful in streamlining their development programs. Receiving the designation can also raise a drug company’s profile, which can facilitate additional investment as well as clinical trial patient recruitment; this is particularly important for smaller companies with limited resources.
Patient and disease advocates were likewise supportive, and expressed hope that the early lessons learned from successful breakthrough therapy approvals (which have been mostly concentrated in the oncology and antiviral fields) could be translated to other disease areas with less success. However, while BTD is an important tool in expediting the development of new drugs, it is just one piece of broader scientific and regulatory policy landscape. Accelerating the pace of discovery and development of truly innovative new drugs will depend on a range of other factors, such as developing and validating new biomarkers that can be used to measure treatment effects at an earlier stage, as well as establishing networks that can streamline the clinical trial process. It will also be important to develop effective new approaches to collecting, analyzing, and communicating information about these treatments once they are on the market, as this information can potentially be used by FDA, providers, and patients to further improve prescription drug policy and medical decision-making.
2. BTD requests far outnumber those that actually meet the qualifying criteria
Since the program began, less than 30 percent of requests have received BTD designation. A substantial majority were denied at least in part due to either a lack of data or problems with the quality of the data, or some combination of the two. For example, some sponsors requested the designation before they had any clinical data, or submitted the request using clinical data that was incomplete or based on flawed study designs. Many requests also failed to meet the Agency’s bar for “substantial improvement” over existing therapies.
One reason for the high denial rate may be a lack of a clear regulatory or statutory bar that could be used as a definitive guide for sponsors to know what is needed to qualify for the designation. BTD denials are also confidential, which means that sponsors effectively have nothing to lose by submitting a request. Going forward, manufacturers may need to exercise more discretion in deciding to request the designation, as the process can be resource- and time-intensive for both sides.
3. There is no single threshold for determining what defines a breakthrough therapy
About 53 percent of the 109 total BTD denials were due at least in part to the fact that the drug did not represent a substantial improvement over existing therapies. During the day’s discussion, FDA and sponsors both noted that this is likely because the criteria for BTD are inherently subjective. In practice, this means there is no clear threshold for determining when a new therapy represents a “substantial improvement” over existing therapies. Designation decisions are complex and highly dependent on the context, including the disease or condition being targeted, the availability of other treatments, the patient population, the outcomes being studied, and the overall reliability of the data submitted. Given the multiple factors at play, it can be difficult in some cases to determine when a new product is potentially “transformational” as opposed to “better,” especially for conditions that are poorly understood or have few or no existing treatments. In making its determinations, FDA considers the totality of the evidence submitted, rather than focusing on specific evidentiary requirements.
4. Early communication with FDA is strongly recommended for BTD applicants
Roughly 72 percent of the BTD denials related at least in part to trial design or analysis problems, which led several people to suggest that sponsors engage with FDA prior to submitting their request. Though there are several formal mechanisms for interacting with the agency, informal consultations with the relevant review division could help sponsors to get a better and much earlier sense of what kind of data FDA might need. This early communication could both strengthen viable BTD requests and reduce the number of frivolous requests.
5. FDA may need more resources for implementing the BTD program
Drugs that receive breakthrough designation are subject to much more intensive FDA guidance and review. However, when the program was established in 2012, Congress did not allocate funding to cover its costs. There have been ongoing concerns that the program is exacting a significant toll on FDA’s already limited resources, and potentially affecting the timeline for other drug application reviews. These concerns were reiterated during the day’s discussion, and some suggested that Congress consider attaching a user fee to the BTD program when the Prescription Drug User Fee Act comes up for reauthorization in 2017.Event Announcement The weakening of the Iraqi government, the Syrian Civil War, and the rise of the so-called Islamic State have reopened questions about the future of Kurds in West Asia. To discuss recent developments and questions about the future of Iraq and Syria, Brookings India is organizing a private roundtable with Peter Galbraith. In […]
Events with extreme temperatures and humidity are occurring twice as often now as they were 40 years ago
-- Read more on ScientificAmerican.com
Southeast Asia is poised for a long-overdue and much-needed boom in solar.
Events, including private rentals, canceled through May 15. One-day cleaning period implemented between rentals of State Park cabins and cottages.
Event held during the celebration of Public Service Recognition Week, May 6-12, 2018. WILMINGTON, Del. (May 11, 2018) —Governor John Carney and Cabinet members celebrated Public Service Recognition Week by applauding the extraordinary work of Delaware’s public servants. Awards for exemplary efforts in service to the State of Delaware were presented at the Governor’s Awards […]
The live streaming feature on social media platforms is seeing a huge uptake during the lockdown
Events presented in honor of Presidents Day 2020.
Event will include scholarly presentations on the history and archaeology of the lower Delaware Valley including the Avery’s Rest and Fort Casimir archaeological sites.
Events to take place at sites across Delaware.
Event cancelled due to unforeseen circumstances.
Event commemorates the 337th anniversary of Penn’s disembarkment at New Castle, his first landing in the New World.
Event to feature decorations and children’s craft activities, plus self-guided tours of the home and refreshments.
Event explores Colonial-era job opportunities at the home of the “Penman of the Revolution.”
Programs explore the importance of railroads to America’s economy and way of life, and their impact on Delaware.
Event provides visitors with an opportunity to experience seafaring lives of adventure, romance, excitement and hardships, and to honor mariners who made the ultimate sacrifice.
Event cancelled due to inclement weather.
Sept. 2, 2017 event moved from outdoors on the Dover Green to indoors at The Old State House.
Eventual vaccine developed to fight COVID-19 should be free to everyone, a letter to the editor says.
Eventual vaccine developed to fight COVID-19 should be free to everyone, a letter to the editor says.
Event cancellations at local bodies due to COVID-19 will reduce revenue, but not rent and other fixed expenses. Many local bodies already operate on extremely tight margins and struggle to pay their bills even during normal times. All members are encouraged to continue to financially support their local bodies, even if there are no events …
Eventide Audio has announced the release of its new dual-voice pitch shifter plugin for Windows and Mac. MicroPitch is the latest incarnation of an iconic effect originated by Eventide in the 1970s. With each generation, Eventide has added to, refined, enhanced and built on its legendary predecessors. MicroPitch is a fine-resolution pitch shifter providing effects […]
The post Eventide’s MicroPitch pitch shifter for Windows and Mac on sale at intro offer appeared first on rekkerd.org.
A computer implemented method of software testing may include obtaining multiple interactive elements from an event-driven software application. The interactive elements may be configured to be selected by a user and when selected result in an event in the event-driven software application. The method may also include determining which of the interactive elements may be user interactive in a first state of the event-driven software application. In some embodiments, determining which of the interactive elements may be user interactive may include obtaining one or more coordinates of a first interactive element and determining if the first interactive element is a top layer interactive element at any one of the one or more coordinates. The method may further include testing the event-driven software application based on the user interactive elements.
Event will also outline practical, low cost water quality testing and treatment solutions that assist project managers and implementers in the field
Event is the Largest Free-Admission 4-H Fair on the East Coast
Event spotlights barbaric treatment of millions of widows around the world, stigma of widowhood