FDA Issues Final Regulation on Dental Amalgam

The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.

Specifically, the FDA recommended that the product labeling include:

• A warning against the use of dental amalgam in patients with mercury allergy;
• A warning that dental professionals use adequate ventilation when handling dental amalgam;
• A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.

Source: FDA

Kargil war lets remember our hero’s

The Kargil War, was an armed conflict between India and Pakistan that took place between May and July 1999 in the Kargil district of Kashmir.

The cause of the war was the infiltration of Pakistani soldiers and Kashmiri militants into positions on the Indian side of the Line of Control (LOC), which serves as the de facto border between the two states.

During and directly after the war, Pakistan blamed the fighting entirely on independent Kashmiri insurgents, but documents left behind by casualties and later statements by Pakistan’s Prime Minister and Chief of Army Staff showed involvement of Pakistani paramilitary forces, led by General Ashraf Rashid.

The Indian Army, later on supported by the Indian Air Force, attacked the Pakistani positions and, with international diplomatic support, eventually forced withdrawal of the Pakistani forces across the LOC.

http://en.wikipedia.org/wiki/Kargil_War

10 years of kargil war lets pay tribute to our Hero’s

Lets pay tribute to our Kargil Hero’s

Medical Device Webinars / trainings @$149 (On-Demand)

Are you looking for online training for Medical Device Industries and Life Sciences?  What all it has -

• 60 minutes of online training
• Convenient access anytime, anywhere
• A great way to meet your educational needs
• Courses for the Life Sciences and Medical Device Industries

Check out here -

1. Basic Requirements for Steam Sterilizer Validation per ISO 17665
2. Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
3. Medical Device Complaints, MDR’s and Recalls
4. Six Sigma Methodology for Process Validation
5. Documenting a Risk-Based Quality System – for Compliance and Cost-Savings
6. How to perform effective supplier audits, and avoid FDA 483’s and Warning letters
7. Verification vs. Validation in Regulated Industries
8. CAPA Essentials – core principles and practices needed to implement an effective and efficient CAPA process
9. Introduction to Process Capability (Cp, CpK, Pp, Ppk)
10. How to Use the System Risk Level to Save Time and Money on Computer System Validations
11. Implementing the new International and FDA accepted Software Development Standard IEC 62304
12. Risk Management Activities during Design Input
13. Developing a Robust CAPA System
14. Complying with 21CFR Part 11-Understanding the Role of Predicate Rules
15. The New Dietary Supplement Good Manufacturing Practices
16. Configuration Management and Change Control for Computer Systems
17. Cleanroom Operation, Maintenance and Operators
18. Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971
19. 510(k) Preparation for a Small to Medium-Sized Company
20. Applying Lean Documents to a Project – how to create a project file, follow design controls, yet maintain a lean set of project documents.

Planning to buy home? Look what you need to know

Well it all starts from

1. Searching Home
2. Check the payment mode which you want
3. Look into Developer agreement
4. Have close eye on Property dealers
5. Choose the right bank/HFC (housing finance company)
6. Once you buy then

Ways of Searching Home

1. Start looking into advertisements in local newspapers
2. Better to approach the bank or the HFC as they already have list of pre approved builders / developers listed.

Check the payment mode which you want

Choose from the 2 available payment modes

1. A lumpsum upfront payment when you choose this you have chance of getting 5-10% discount (But I would said not to opt this one)
2. One that is construction-linked – best option to go with

Look into Developer agreement

Check for

1. Exit clause
2. Approved building plan are made a part of the agreement

Have close eye on Property dealers

1. Don’t belive them blindly
2. Check creditibility before you select

Choose the right bank/HFC (housing finance company)

Look at its response to interest rate movements. Look at how it revised its rates during the boom period. Choose an institution that is proactive in changing its home loan rates when interest rates move up or down.

From December 2009 you will have access to your credit score. Use a good credit score to get a better rate of interest on your loan.

Once you buy then

1. Regularly visit the construction site to check the progress
2. Get in touch with others invested in the project.

Check rediff to know more

e-Filing Process (TAX)

E-Filing Tax

1. Select appropriate type of Return Form
2. Download Return Preparation Software for selected Return Form
3. Fill your return offline and generate a XML file.
4. Register and create a user id/password
5. Login and click on relevant form on left panel and select “Submit Return”
6. Browse to select XML file and click on “Upload” button
7. On successful upload acknowledgement details would be displayed. Click on “Print” to generate printout of acknowledgement/ITR-V Form.

Click here to know more

Source: Income Tax Department, India.

Stuck in debt & don’t know how to cope up

1. Try to lower your interest rate. Negotiate with your bank. One other way is to convert your credit card debt into a personal loan debt. It will definitely be lesser than the credit card interest rate.
2. Calculate your net worth and see if any of your investments could help you prepay a part of your loans.
3. Make a contingency plan for the immediate future. Talk to your bank along with your debt counselors and explain your situation and see if you can resume your loan at a later date but do make an effort to prepay some amount.
4. If it is a double-income household, try and see if your spouse can support you in the event of a job-loss in the short term before you land a job.
5. Manage your current finances judiciously to battle through the current situation and emerge wiser.

Source: BankBazaar.com

New tax slabs after Budget 2009

Highlights of Budget 2009

* Growth rate in 2008-09 dipped to 6.7 per cent from average 9 per cent growth in previous three fiscal years.

* Mukherjee intends to make pre-budget consultations with state finance ministers an annual affair

* Fiscal deficit grew from 2.7 per cent to 6.8 per cent of GDP

* We need institutional reforms to being fiscal deficit down, says the FM.

* Total fiscal stimulus during 2008-09 amounts to Rs 1,86,000 crore.

* To return to FRBM target for fiscal discipline at the earliest, says Mukherjee.

* Fiscal deficit in 2009-10 is proposed at 6.8 per cent of GDP.

Taxes

* Share of direct taxes has increased to 56 per cent in 2008-09 over 41 per cent in 2007-08.

* Direct Tax code to be released in 45 days along with discussion paper.

* Effort is to improve tax collection by eliminating distortions in tax system and expanding the base

Tax proposals

* No change in Corporate Tax.

* Ten per cent surcharge on personal income tax removed.

* I propose to raise by Rs 10,000 the exemption limit for women on income tax. For all others, Rs 10,000 up from Rs 1,50,000, says Mukherjee.

* Income Tax rates exemption limit to 2,25,000 to 2,40,000 for senior citizens.

* Fringe benefits tax abolished.

* Tax holidays extended by one more year.

* Commodities transaction tax abolished.

* Proposal to incentivise business. I propose to start Investment linked tax benefits in areas of agriculture and national grid, says Mukherjee.

* To further improve the efficiency of tax system, I propose to set up two authorities for advance ruling, says Mukherjee.

* Minimum Alternate Tax on book profits increased to 15 per cent from 10 per cent.

* New pension system trust exempted from security transaction tax and dividend distribution tax.

* Income tax incentives on education loans expanded to cover vocational studies after schooling.

* Small businesses up to Rs 40 lakh turnover exempted from filing advance tax returns.

* Presumptive Taxation of 8 per cent on businesses of turnover of up to Rs 40 lakh.

* Service Tax to be extended to lawyers on technical advice.

* Service tax exempted for exporters on select services.

* IT returns to be made simpler, says Mukherjee.

* Govt to extend tax waiver on some exports to March 2010.

Source:  TImes Now

Budget 2009

1. Fringe Benefit Tax to be abolished
2. Plan expenditure for centre, states increased
3. I-T exemption limits raised by Rs 10,000
4. New IITs get Rs 2,113 crore
5. Defence budget raised by 34 per cent
6. Govt to provide rice, wheat at Rs 3/kg
7. Commonwealth Games allocation increased
8. Crop loan at 6% interest for farmers
9. Get your unique ID card in a year
10. Students get full interest subsidy
11. NREGA: Govt to provide Rs 100 a day as wages
12. Incentive to pay back agricultural loans
13. Infrastructure growth to get a boost
14. Fiscal deficit rises to 6.8% of GDP
15. Govt to revive GDP growth to 9%

More yet to come