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Daylight Saving Time in a nutshell - a brief history.

We all are familiar with the phrase, "Spring Forward, Fall Back," and what it means to us every year.

Since 1966, most of the US has observed the daylight saving time changes twice a year with our clocks.

Where did this 'timely tradition' begin?

Back in 1784, Benjamin Frankl

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

in suggested that people wake up earlier to use less wax for candles and use more sunlight. He didn't actually suggest changing the clocks but was being humorous in his comment.

A British official worked to promote Daylight Saving Time changes in 1907, but his efforts were not successful.

Germany in 1916 seems to be the first succes

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

sful country to implement Daylight Saving Time changes. The UK was second to use the Daylight Saving Time shortly after the same year.

Newfoundland was next the following year to follow the Daylight Saving Time changes.

Then, in 1918, Daylight Saving Time was temporarily put into law in the United States at the same time Time Zones

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

were Established. Unfortunately, it was short lived and the Daylight Saving Time Changes were repealed shortly thereafter in 1919.

Finally, it was reintroduced and became a law again in 1966 in the US and has remained a law since.

In 1986, President Reagan changed Daylight Saving Time from the last Sunday in April to the first Sunda

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

y in April but didn't change the ending date, of which, is the last Sunday in October.

President George W. Bush signed the Energy Policy Act of 2005 into law August 2005. The NEW Daylight Saving Time change format is now:

Second Sunday in March - Clocks go ahead one hour.
First Sunday in November - Clocks fall back one hour, ex

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

tending the Daylight Saving Time schedule.

One aspect to Daylight Saving Time is that the law does not require that anyone observe Daylight Saving Time. Basically, if we are going to observe Daylight Saving Time, it must be done uniformly.

Daylight Saving Time and Technology.

Since the last change in the Federal back in 1986, most

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

of technology that depends on time changes have their own means and methods of 'correcting' themselves to stay in sync with the proper time zones and Daylight Saving Time.

Well, thanks to the new legislation signed into law in 2005 that changes the Daylight Saving Time start and end range, 11 March 2007 may bring some discomfort to mo

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

dern technology. There may be some subtle difficulties, such as PC clocks and handheld devices, but there are other problems that may arise.

According to an email from a major financial corporation sent out to thousands of it's employees nationwide:

***********************************

"Daylight Saving Time 2007

The Ene

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

rgy Policy Act of 2005 extended the time period for Daylight Saving Time in the United States. Beginning this year, DST will begin on the second Sunday in March (the 11th) and end the first Sunday in November (the 4th). As a result, all computers and servers must be updated with the new DST rules. Microsoft has released a patch for the

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

Windows XP and Windows 2003 Server operating systems. We are testing the patches and will be installing them soon. Windows 2000 systems (servers and computers) can be updated with the new rules but it will require a different approach. Unfortunately, updating the DST rules is not the only action necessary to prepare for this change. A

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ll associates using the Outlook Calendar will be impacted by this change. In order for Outlook to see the new DST rules, an update tool must be run on every user's PC. Once the tool is released we will provide an update on how it will be distributed. In the meantime, there are a couple of things that users can do to make the transition

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

easier. Everyone should give extra attention to appointments scheduled during the new DST time period (March 11, 2007 to April 1, 2007 and Oct 28, 2007 to November 4, 2007). To minimize confusion during the affected date ranges, Microsoft suggests including the time of the meeting in the subject line of the request. After March 11th,

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

all appointments in the date ranges specified should be confirmed by the Meeting Organizer. This action will ensure that the item shows up correctly on everyone's calendar both internally and externally. As you can imagine there are many other systems that might be impacted by this change. IT will be looking at all systems it manages a

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

s well as contacting business areas to verify that their systems are being updated as needed. The list of impacted systems could include anything from the Heating/AC system to Access Door Controls to Trading Systems and Blackberries."

***********************************

Can you imagine that? Everything from Meeting time

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

s to Alarm Systems to Trading Systems!

Can you spell 'chaos?'

How is this going to affect your everyday computing from home, work, or the office? How about schedules pertaining to education such as your child's schooling or college?

Getting back to PCs and the affects that the Energy Policy Act of 2005 may bring, a little research

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

has been conducted on how your current Windows Operating System will react. While scrubbing Microsoft's website, a bit of information was found that was quite interesting, to say the least.

If you are using Windows 95 to Windows XP (Service Pack 1) then you may be in for a surprise. ONLY Windows XP Service Pack 2 and beyond (SP 3 an

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

d Vista) will be supported!

What does this mean?

That's simple:

You will either have to change your clocks 4 times a year by yourself, OR
Pay for a patch.

Have you ever attempted to 'patch' or update your PC before? Lots of fun, wouldn't you agree?

Here are some of the current dates that will need to be cha

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

nged on your PC thanks to the new DST time changes now in effect:

Your PC will need to be put ahead 11 March 2007.
Since your PC will be ahead already, you will need to set the PC clock back manually on 1 April 2007.
Your PC will be set to change back on 28 October 2007, so you will need to set it ahead on that date

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

to stay in sync with the rest of the world.

You will need to reset the PC Clock back manually an hour on 4 November 2007 to get back to time with the rest of the world.

Now, THIS is just the beginning! You will have to do this on the scheduled date for EACH YEAR from this point forward, that is, unless they change the

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

schedule back again. However, it took almost 60 years to get the date range to where it's at, do you think that it will change again soon?

There IS a solution to this madness however, in relation to your PC.

Check out DST-Update.com to fix your PC and get back to doing the things that are most important to you. Now, THAT'S Freedom

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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