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February FDA NDA/BLA Approvals

2/01 Cosopt PF, Merck Sharp Dohme; 2/03 Giazo, Salix Pharmaceuticals ; 2/07 Mitosol, Mobius Therapeutics;
2/07 Sklice, Sanofi-Topaz; 2/10 Zioptan, Merck Sharp Dohme



1/3 of candidates don't get hired because of “digital dirt” that follows them

Applying for a new job? Chances are that if your resume makes the grade, your new employer is going to plug your name into Google long before ever picking up the phone to call you back in. Just think about how often you do a quick Internet search before or after meeting a prospective client, supplier, hire, date, etc. In a recent survey of 100 executive recruiters by execunet.com, 77 percent of respondents said they use the Internet to uncover additional information about candidates. A third of those managers had eliminated applicants based on what they found. So while your work history might be spotless, a scandalous photo on Flickr.com, a tasteless comment on YouTube.com, or even an ill-advised political rant can get you blackballed. The first 3 pages of search engine results reveal a lot about a person. But the idea is: If there's enough content about you that's positive, it will camouflage the negative. Take the following steps to ensure that the next time your name gets typed into a search engine, those results uncover a spotless reputation.

Start a Blog
The benefits to starting a blog are many. One of the best is credibility. If you start a blog about your area of business expertise and write insightful stories on a regular basis—with proper grammar and all of your i's dotted and t's crossed—that can position you as an expert in your field and can help overturn any negative press or comments that may have been posted about you online. And because blogs are endorsed by their authors, they usually appear first in search results, which are ranked in order of recent updates, originality, and authoritativeness. To get started with your own blog, take a look at the top three most popular blogging services: Blogger (www.blogger.com); TypePad (www.typepad.com); WordPress (www.wordpress.com)

Create a Web folio
Short for website portfolio, a Web folio is a simple website that showcases your resume and other accolades. In other words, it's a website about you where others can go to learn more about you. The domain name should be your first and last name and the more of your accomplishments that you exhibit here, the better. Potential employers, and anyone else visits your Web folio, will want to not only view your work experience, but also get a feel for who you are and your personality. If you communicate all of this in a friendly, yet professional tone, convincing a recruiter or potential business partner that you're not the wild party animal that Flickr makes you out to be might take only a few minutes, as opposed to days or never. Here are a few good examples of what a Web folio should look like: Logan Kugler (www.logankugler.com); Chris Saribay (www.chrissaribay.com); Linda Formichelli (www.lindaformichelli.com)

Flesh Out Your LinkedIn Profile
Nearly 20 million business professionals are on LinkedIn. If you're not one of them, you're missing out. Not only is it the best networking tool in the world, but your LinkedIn profile can double as your online resume, even if you don't actively use the website to network. However, getting your LinkedIn profile page to appear first in search engine results will require you use the site to its full capability. While LinkedIn is incredibly useful in so many ways, one of the best ways to counter any e-skeletons you may have hiding in your closet is by getting people you've worked with in the past to write short recommendations about you which appear on your profile. Here's a great article by Guy Kawasaki about how to make sure your LinkedIn profile is operating on all cylinders: http://blog.guykawasaki.com/2007/01/linkedin_profil.html

Promote Your Web Pages
The best way to increase the ranking of your favorable web pages is by doing some guerrilla marketing. When you write a great story on your blog that you think others would be interested in, submit it to websites like Digg (www.digg.com) and Slashdot (www.slashdot.org). Another great way to increase traffic is by sending a link to the top blogs covering your industry. For example, if your blog is in the realm of technology, you can send a link to your story to top blogs like Gizmodo (www.gizmodo.com) and Engadget (www.engadget.com) as a news tip. Just make sure the story is new or original—blogs don't like using anything but the latest content, especially the bigger ones. And if you haven't already, add a link to your Web folio and mention your LinkedIn profile in your e-mail signature. Finally, don't forget to utilize your LinkedIn connections. Once you've got a few posts up on your blog, send a note to all of your connections asking if they'd like to subscribe to your blog.

Written By Logan Kugler

Bureau of Labor Statistics Report (November 2009)

The Bureau of Labor Statistics reported this morning that unemployment in the United States has risen from 9.8 percent to 10.2 percent, while shedding 190,000 positions. Revisions to job loss estimates from August and September caused the total losses over the previous two months to decline by 93,000 fewer positions than previously reported. It is not uncommon for the labor market to begin to see some improvement and for people who had sat on the sidelines to re-enter the workforce. Currently 2.2 percent of the U.S. workforce falls into that category, its highest point since 1983.

While the rate of job losses continues to be substantial and the top line numbers keep declining, the most leading indicators of the job market are starting to heal. The reversal for temp workers, an increase in re-entrants, and a decrease in unemployment for those with a 4-year degree or higher from 4.9 to 4.7 percent­ all point towards early signs of improvement.


After adding just 3,000 jobs in September, professional and business services added 18,000 jobs in October, marking just the second positive reading for the sector since the beginning of the recession. Within the professional and business services sector, the biggest winner was temporary help services which added 33,000 positions, after having lost upwards of an average of 40,000 per month in all of 2008 and the first half of this year. Other categories also adding jobs, though not as impressively, include accounting and bookkeeping services (3,800), management and technical consulting (7,300), computer system design and related services (4,500), securities, commodity contracts and investments (500). While the overall retail industry remained weak, losing just shy of 40,000 positions, health and personal care stores, home furnishings, and clothing stores added positions during the month.

(Scroll Down for a list of open positions)

FDA nominee says agency confidence boost needed

As Reported on Reuters.com:

By Lisa Richwine
WASHINGTON, May 7 (Reuters) - President Barack Obama's nominee to run the Food and Drug Administration pledged on Thursday to boost public confidence in the agency with a focus on improving the safety of medical products and foods.
"The American people place a huge amount of trust in the FDA. It is critical that we take steps to boost their confidence, particularly when it comes to the safety of drugs and foods," Dr. Margaret Hamburg told the Senate health committee.
If confirmed by the Senate, Hamburg will take over an agency battered in recent years by a string of often deadly food poisoning and drug safety issues.
Improvements in those areas will be a priority, she said.
For foods, Hamburg said: "Now is the time to shift to a food safety system that puts prevention first."
Close monitoring of medical products after approval would be key to identifying safety problems early and responding quickly, she said.
Hamburg also said fostering innovation was a priority and that she would "strive to lead an agency that appropriately balances innovation with regulation."
Democrats and Republicans alike praised Hamburg, a Harvard-trained doctor and former New York City health commissioner, as being well-qualified with expertise in public health and bioterrorism preparedness.
Senator Patty Murray, a Democrat who chaired the hearing, said she would push for speedy approval of Hamburg's nomination so she could get to work on the multitude of pressing issues facing the agency.
The FDA oversees prescription and over-the-counter drugs, medical devices, most foods and other products that account for about one-quarter of the U.S. economy.
Lawmakers urged Hamburg to look at a range of issues from the new H1N1 flu strain to the safety of imported foods and medicines and oversight of tobacco, which Congress may put in the FDA's hands.
Many asked Hamburg to fix low morale at the agency after complaints that politics has trumped science in some of the agency's decisions.
Hamburg said she would aim to "create an environment where scientists feel very free to raise issues and concerns without any fear of retaliation."
"I think science is best served by robust discussion," she said.
On the new flu strain seen in many countries, Hamburg said she would look into whether more could be done to make flu-related medical products and laboratory tests available. (Editing by Dave Zimmerman, Maureen Bavdek and Ted Kerr)

IRS 20 Point Checklist for 1099 Workers

The IRS has realized the large sums of potential tax revenue they are losing due to misclassified 1099 independent consultants who should legally be W-2 employees. When a company pays a consultant on a 1099-misc form, they avoid the following: federal and state tax withholdings, deposits and reports, the employer's share of Social Security and Medicare taxes, state and federal unemployment insurance premiums, state disability insurance premiums, Workers' Compensation costs, fringe benefits, vicarious liability for employee negligence, and EEOC regulations. The IRS estimates that it loses from $4 to $20 billion per year in unpaid taxes as a result of this misclassification problem.

With the added pressure of additional revenue needed at the federal and state level, understandably, the IRS and many states have made it a priority to investigate 1099-misc forms that are turned in at the end of the tax year. In addition, a bill, The Employee Misclassification Prevention Act would amend the Fair Labor Standards Act, has been introduced in the congress which will create additional oversight for auditing and additional penalties for non-compliance.

Make sure you are safe. Below is a 20 point checklist used by the IRS and legal system to determine classification.
If there is a chance that your use of consultants falls within this misclassification, don’t take the risk in today’s environment. You still have the ability to bring individuals on in an hourly fashion legally, by contracting them through a staffing organization. They become w-2 employees of our organization and can legally work for your organization on a contract basis as they are no longer paid an a 1099-misc form.

IRS 20 Point Checklist for 1099 Workers
Specific factors that are used by the IRS in determining whether an individual is an employee (W-2) or an independent contractor (1099) are listed below. This listing is commonly referred to as the "20 factors" test. This 20-point checklist is only a guideline; it does not guarantee that a person is correctly classified. Most agencies and courts typically look to the totality of the circumstances and balance the factors to determine whether a worker is an employee.

1. Must the individual take instructions from your management staff regarding when, where, and how work is to be done? A worker who is required to comply with other persons' instructions about when, where, and how he or she is to work is ordinarily an employee. This control factor is present if the person or persons for whom the services are performed have the right to require compliance with instructions.
2. Does the individual receive training from your company? Training a worker by requiring an experienced employee to work with the worker, by corresponding with the worker, by requiring the worker to attend meetings, or by using other methods, indicates that the person or persons for whom the services are performed want the services performed in a particular method or manner.
3. Is the success or continuation of your business somewhat dependent on the type of service provided by the individual? Integration of the worker's services into the business operation generally shows that the worker is subject to direction and control. When the success or continuation of a business depends to an appreciable degree upon the performance of certain services, the workers who perform those services must necessarily be subject to a certain amount of control by the owner of the business.
4. Must the individual personally perform the contracted services? If the services must be rendered personally presumably the person or persons for whom the services are performed are interested in the methods used to accomplish the work as well as in the result.
5. Have you hired, supervised, or paid individuals to assist the worker in completing the project stated in the contract? If the person or persons for whom the services are performed hire, supervise, and pay assistants, that factor generally shows control over the workers on the job. However, if one worker hired supervises, and pays the other assistant pursuant to a contract under which the worker agrees to provide materials and labor and under which the worker is responsible only for the attainment of a result, this factor indicates an independent contractor status.
6. Is there a continuing relationship between your company and the individual? A continuing relationship between the worker and the person or persons for whom the services are performed indicates that an employer-employee relationship exists. A continuing relationship may exist where work is performed at frequently recurring although irregular intervals.
7. Must the individual work set hours? The establishment of set hours of work by the person or persons for whom the services are performed is a factor indicating control.
8. Is the individual required to work full time at your company? If the worker must devote substantially full time to the business of the person or persons for whom the services are performed, such person or persons have control over the amount of time the worker spends working and impliedly restrict the worker from doing other gainful work. An independent contractor, on the other hand, is free to work when and for whom he or she chooses.
9. Is the work performed on company premises? If the work is performed on the premises of the person or persons for whom the services are performed, that factor suggests control over the worker, especially if the work could be done elsewhere.
10. Is the individual required to follow a set sequence or routine in the performance of his work? If a worker must perform services in the order or sequence set by the person or persons for whom the services are performed, that factor shows that the worker is not free to follow the worker's own pattern of work but must follow the established routines and schedules of the person or persons for whom the services are performed. Often, because of the nature of an occupation, the person or persons for whom the services are being performed do not set the order of the services or set the order infrequently. It is sufficient to show control, however, if such person or persons retain the right to do so.
11. Must the individual give you reports regarding his/her work? A requirement that the worker submit regular or written reports to the person or persons for whom the services are performed indicates a degree of control.
12. Is the individual paid by the hour, week, or month? Payment by the hour, week, or month generally points to an employer-employee relationship, provided that this method of payment is not just a convenient way of paying a lump sum agreed upon as the cost of a job. Payment made by the job or on a straight commission generally indicates that the worker is an independent contractor.
13. Do you reimburse the individual for business/travel expenses? If the person or persons for whom the services are performed ordinarily pay the worker's business and/or traveling expenses, the worker is ordinarily an employee. An employer, to be able to control expenses, generally retains the right to regulate and direct the worker's business activities.
14. Do you supply the individual with needed tools or materials? The fact that the person or persons for whom the services are performed furnish significant tools, materials, and other equipment tends to show the existence of an employer-employee relationship.
15. Have you made a significant investment in facilities used by the individual to perform services? If the worker invests in facilities that are used by the worker in performing services and are not typically maintained by employees (such as the maintenance of an office rented at fair value from an unrelated party), that factor tends to indicate that the worker is an independent contractor. On the other hand, lack of investment in facilities indicates dependence on the person or persons for whom the services are performed for such facilities and, accordingly, the existence of an employer-employee relationship.
16. Is the individual free from suffering a loss or realizing a profit based on his work? A worker who can realize a profit or suffer a loss as a result of the worker's services (in addition to the profit or loss ordinarily realized by employees) is generally an independent contractor, but the worker who cannot is an employee.
17. Does the individual only perform services for your company? If a worker performs services for a multiple of unrelated persons or firms at the same time, that factor generally indicates that the worker is an independent contractor.
18. Does the individual limit the availability of his services to the general public? The fact that a worker makes his or her services available to the general public on a regular and consistent basis +indicates an independent contractor relationship.
19. Do you have the right to discharge the individual? The right to discharge a worker is a factor indicating that the worker is an employee and the person possessing the right is an employer. An employer exercises control through the threat of dismissal, which causes the worker to obey the employer's instructions. An independent contractor, on the other hand, cannot be fired so long as the independent contractor produces a result that meets the contract specifications.
20. May the individual terminate his services at any time? If the worker has the right to end his or her relationship with the person for whom the services are performed at any time he or she wishes without incurring liability, that factor indicates an employer-employee relationship.

NOTICE: Management Recruiters of Vancouver has provided the content of this document for general informational purposes only. You should not substitute this information for personal consultation with a qualified professional in the field, nor should you rely upon this information in taking any action. No attorney-client relationship will be created through your use of this document.