CeSub eSubmitter

May 30, 2008

The Center for Devices and Radiological Health (CDRH) has an electronic submissions program, referred to as CeSub (CDRH electronic Submissions). CeSub evolved as a result of two very successful pilot programs named “eLaser,” and “Turbo 510(k)”. The CeSub program prepared the next version of the software, a new tool to collect submission data. This new software tool is called CeSub eSubmitter. CeSub eSubmitter is an improved and expanded package for a variety of submission types and is now available for voluntary use by the sponsors and manufacturers in the device and Radiological Health industries.This software application is intended to automate the current paper submission process to the OIVD, Rad Health and Medical Device Adverse Event (MDR) programs.

CeSub eSubmitter is free software that allows sponsors to:

Electronically complete and submit premarket notification applications [ 510(k)] to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Electronically complete and submit information for a variety of radiation safety Product Reports and Annual Reports for radiation emitting products to the Radiological Health Program.

Electronically complete and submit the Medwatch 3500A form for medical device adverse event reports.

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Click here to learn Successful 510(k) Submissions

Source: FDA

21CFR Part 11 compliance for spreadsheets

May 29, 2008

The Food and Drug Administration (FDA) in the United States designed Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) to help ensure that life sciences companies can use electronic records and signatures that are equivalent to those based on paper and ink. However, initiating and maintaining Part 11 compliance can be complex and costly.

The FDA’s 21 CFR Part 11 regulation applies for2):

• Spreadsheets containing records that are required by the underlying predicate rules such as 21 CFR Parts 210 and 211 (cGMP), Part 820 (QSR) or Part 58 (GLP)
• Spreadsheets containing records that are created, modified,maintained,archived, retrieved or transmitted in electronic form, or are submitted to FDA in electronic form

Compliance requirements for Part 11include both technical as well as procedural
controls. A growing number of pharmaceutical, biopharmaceutical, laboratories and other FDA regulated firms are turning to Commercial Off The shelf (COTS) software solutions for implementing Part 11 compliance.

21 CFR Part 11 compliance requirements

Security: Spreadsheets must be fully secure from unauthorised access and must be protected throughout the record retention period. User management functions should include a clear definition of valid users that are allowed access to spreadsheets, password masks to prevent passwords that are easy to guess and multiple levels of privileges to limit access to supervisory level functions such as review or approval of data.

Audit trails: Per 21 CFR11.10(e), systems subject to Part 11 must employ the “use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions thatcreate, modify or delete electronic records

Electronic signatures: An electronic signature must include three components:the printed name of the signer, the date and time when the signature was executed and the meaning associated with the signature (eg review,approval, responsibility, or authorship).

Source: ComplianceOnline

New Law Prohibits Genetic Discrimination

May 29, 2008

The newly enacted Genetic Information Nondiscrimination Act of 2008 (“GINA”) adds individual genetic information to the list of protected employee characteristics. Under the law, “genetic information” is defined to include information about an individual’s genetic tests, genetic tests of family members, and the “manifestation of a disease or disorder in family members.”

GINA generally applies to public employers; private employers with 15 or more employees; employment agencies and labor organizations; and makes it an unlawful employment practice to refuse to hire, discharge or otherwise discriminate against any employee because of genetic information (GINA also prohibits health insurers from using genetic information to determine insurance eligibility or to increase insurance premiums).

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Child Labor Introduction

May 28, 2008

Federal child labor rules are established by the Fair Labor Standards Act (FLSA). This Act establishes minimum wage, overtime pay, recordkeeping, and child labor rules affecting full- and part-time workers in the private sector and in the Federal, state and local governments. The rules vary depending upon the age of the young worker and his or her occupation.

Two things are certain:

  1. Once an employee is 18, there are no Federal child labor rules.
  2. Federal child labor rules do not require work permits. However, the Department of Labor will issue age certificates if your state does not issue them and you are asked to provide them by your employer.


10 things to avoid at your job interview

May 27, 2008

However good your CV is, if you can’t present yourself properly during the interview, it can’t get you the job. There are many small mistakes that candidates commit, costing them the opportunity and the job.

Arriving late and ignoring explicit instructions:

This is the first mistake that can give a negative impression. As you go for an interview, the interviewer spares some time to meet you. Your arriving late will probably disturb their work schedule.

Try to reach on time and if you are getting late for any reason, make sure that you inform the interviewer. Also, make sure that you follow all the instructions provided to you to appear for the interview. Ignoring the explicit instructions shows your “I don’t care” attitude.

Don’t be a job beggar

Approach the interview as a problem solver and not as a job beggar. It is not the beggars who are hired; it is the people who have a capability to solve the employer’s problems, who are hired. The employer has a problem to which you have a solution, so it is a give and take relationship. Employers respect people who respect themselves.

Going without preparation

Prepare yourself for the obvious questions. Not being able to reply to the general questions properly gives a bad impression. Make it a point to research the company and its business before you go for an interview.

Not having the basic knowledge about the company shows that you are not interested in the job. This is one of the biggest mistakes you can commit as an interviewee. Akash replied to a notification requiring Corporate Communication Managers and with his impressive CV, he managed to secure an interview call.

Not analysing the job profile and requirements

This is another big mistake that many candidates commit. If you do not take the time to understand the job profile and requirements properly, you cannot expect the questions the interviewer might have. Moreover, you will not be able to dispel the interviewer of the doubts s/he may have regarding your candidature on that profile.

Badmouthing your previous company

During an interview, do not criticize your last employer. The prospective employer will try to relate himself to your last employer and your badmouthing can give them the impression that you are a misfit. Most employers try to judge your attitude through this question. Speaking negatively about your place of work might give them the feeling that you are not an easy person to get along with.

Telling lies about your candidature

Remember that you have a right to remain silent over the things that you don’t want to disclose. It is not necessary that you provide them the details of every inch of your career but make sure that you do not tell lies about your candidature. These lies may get you hired but they can be a big reason for you being fired as well.

Sounding money-minded

Employers do not like people who switch jobs for couple of thousand rupees. Although money is a major attraction, do not talk about the salary and benefits before you are offered the job. let the interviewer begin the discussion on the salary.

Not asking questions to the interviewer

Almost all interviewers give the candidate a chance to ask questions. This is something you can always expect. Prepare yourself to ask some intelligent questions about the company, business, your chances to grow in the organisation etc. By not asking questions you might give the impression of being uninterested or indifferent.

Failing to send a thank you note

Do not fail to send a thank you note to the interviewers within 24 hours of your interview. This will keep you fresh in their minds and give them another chance to let you know if they have any concerns regarding your candidature.

You have all the right to speak for yourself during the interview and sell your skills but do not go overboard by interrupting the interview or arguing with him/her. This might give the interviewer the impression of over-confidence instead of confidence.

Source: Rediff

Negotiating salary? 4 important tips

May 27, 2008

There are many of us who get lured with the numbers that show in our CTC package, but when the actual take-home salary comes in our hand, it causes a lot of heartache. It is therefore very important that when you are negotiating the salary, you should have a clear idea about numbers. A good way to achieve this is by using tax saving strategies that would reduce your burden.

Ah! those slips that snip

The first thing to look for is the different heads in your salary package. Heads like performance incentive sound challenging, but they are always taxed. Special allowances, added with conveyance and phone reimbursement, also attract tax.

Often, there is a notion among salary-earners that a lesser basic pay and high allowances may bring down income tax burden. However, it is best if you avoid this approach. A reduced basic salary leads to a lower provident fund, which is a forced saving for your future.

Anyone who gets many allowances must combine all of them under a single head. Put car allowance, books reimbursement, house rent allowance, office travel allowance, phone, vehicle and staying in hotels under on head, which straight away lowers your tax bill. Call this consolidated allowance.

Allowances that help

Always go for conveyance allowance. A sum of Rs 800 a month is tax-free. Even if your office does not give conveyance allowance, you can ask for a reduced basic pay and additional conveyance allowance. This move can cut down tax outgo.

Daily allowance, wherever allowed, must be grabbed with both hands because it carries total tax exemption. Professional tax, up to Rs 2,500, is also unencumbered by tax. Also, office loans for car or personal reasons can be used to avoid taxation to a great extent.

Policies that pay

Employees State Insurance Scheme, if available, must be compulsorily availed. Unlike LIC [Get Quote] schemes, the amount is absolutely free from income tax. Fidelity Guarantee Scheme is another insurance plan that is completely tax-free.

Even if you are contributing to a Public Provident Fund, a salaried individual must also opt for Employers Provident Fund, because this also doesn’t attract tax. Many salaried people are unaware that a loan for medical treatment is exempt from income tax under Rule 3 A, but make sure that your medical insurance policy is not utilised.

Avoiding FBT

The fringe benefit tax can be avoided if you own a car and the company pays for maintenance and petrol bills. The most profitable way to claim HRA is to ask the company to take a house on lease, which is owned by any of your relatives. If it’s your parents, who don’t have any income, it works completely to your advantage.

It is because, on one hand, you claim HRA and they, having zero income, don’t have to pay any tax. In fact, even if they have some income, but less than the stipulated base limit of Rs 220,000 a year (assuming they are retired), they would gain from the situation. The maximum benefit occurs when the rent is over 20 per cent of your salary.

When gift vouchers are given, insist on taking them under the employee welfare scheme.

Mobile phone bills are considered a perquisite and taxed, causing your office to fret a lot. You can again offer tax counselling by suggesting a simple trick.

The mobile phone bills can be placed under “recurring operative expenditure” head. All taxes are eliminated at one stroke. At home, leased phone landlines installed at the company’s behest and cost, allows you to get rid of paying tax on calls.

Travel expenses and hotel stays are taxed under FBT. In fact, even a conference to discuss reducing tax incidence on perquisites will also be taxed! However, by not showing the expenditure as conference/seminar and calling it “convention” would remove the tax burden.


Bush’s Indian pal under SEC scanner

May 26, 2008

The SEC’s complaint, filed in the US District Court for the Southern District of Florida, charges Dr Zachariah, 58, a Fort Lauderdale, Florida-based cardiologist, and his brother, Dr Mammen P Zachariah, 60, also a cardiologist, with illegal trading in the shares of two unrelated companies.

The SEC alleges that Dr Zach Zachariah, a board member at pharmaceutical company IVAX Corporation, began illegally trading in IVAX securities only minutes after he learned that IVAX might be acquired by Teva Pharmaceuticals Industries, Ltd. He tipped off his brother, who then purchased IVAX shares.

The SEC’s complaint further alleges that the two brothers and Dr Zach Zachariah’s friend, Dr Sheldon Nassberg, 66, an endocrinologist, also engaged in illegal insider trading in the stock of an unrelated company, Correctional Services Corporation, around the same time as the illegal IVAX trading.

Linda Chatman Thomsen, director of the SEC’s Division of Enforcement, said, ‘The use of inside information to trade ahead of mergers and acquisitions undermines investors’ faith in the integrity of our public markets. This action demonstrates that we will continue to vigorously pursue actions against those who engage in such misconduct.’

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US Biotechnology and regulatory framework

May 23, 2008

Biotechnology in the United States is regulated by at least five Federal agencies in a Coordinated Framework:

1. The Environmental Protection Agency (EPA)

2. Department of Agriculture (USDA)

3. National Institutes of Health (NIH)

4. The Occupational Safety and Hazard Administration (OSHA) and

5. To a small extent the Food and Drug Administration (FDA)

Major Laws that Empower Federal Agencies to Regulate Biotechnology
Law Agency
The Plant Protection Act USDA
The Meat Inspection Act USDA
The Poultry Products Inspection Act USDA
The Eggs Products Inspection Act USDA
The Virus Serum Toxin Act USDA
The Federal Insecticide, Fungicide, and Rodenticide Act EPA
The Toxic Substances Control Act EPA
The Food, Drug, and Cosmetics Act FDA, EPA
The Public Health Service Act FDA
The Dietary Supplement Health and Education Act FDA
The National Environmental Protection Act USDA, EPA, FDA
Source: Pew Initiative on Food and Biotechnology

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$80bn Indian mega-hub proposed

May 23, 2008

The Indian government is close to rubber-stamping an $80bn industrial hub near Vishakhapatnam (Vizag) which is expected to attract pharmaceutical companies to the region. A consortium of Mittal Energy Investments, Total SA and Petroleum Corp will be the anchor tenant at the mega oil, chemical and petrochemical hub following its $7.5bn investment.

Surrounding this will be numerous pharmaceutical and chemical manufacturing facilities, spread over the 603 sq km site.

The sheer scale of the site and the investment should ensure that it becomes a focal point for pharmaceutical activity within India. At this time it is unclear which pharmaceutical companies will be setting up in the region.

The operating in India the hub at Vizag should prove alluring to pharmaceutical companies owing to its scale plus the surrounding geography, culture and infrastructure.

Companies operating in the hub will be looking to utilise the large number of highly educated, English speaking graduates from the region’s educational establishments.

It is this workforce which has driven the rapid growth of Vizag from a small fishing village during colonial times to the industrial monolith it is today.

This industrial expansion has been supported by improvements in the region’s infrastructure.

Consequently, the hub will have excellent links by air, which have undergone rapid improvement in recent years. This has resulted in increased capacity for international airlines and permission for night flights. The city is also well connected to the rest of India by air and rail.

This should facilitate the movement of people to the hub, as well as the transport of goods to market. Vizag’s natural harbour will also play a vital role in dealing with exports, which are anticipated to be $13.6bn per annum.

Infrastructure at the hub itself is to be developed through significant governmental funding, with central government pumping in $1.2bn and the state, Andhra Pradesh, supplying $500m.

The sums of money involved signify the commitment of the Indian government to see the nation build on the impressive growth it has achieved in recent years.

Source:in-Pharma Technologist.com

What Foreign Companies Need to Know about Litigation in America before Entering the U.S. Market

May 23, 2008

Despite the beginning of the “credit crunch” and the collapse of the housing market, 2007 was a banner year for foreign direct investment in the United States, which ranked second, behind China, in the number of new and expanded foreign projects. Behind the bad news is a silver lining – the decline in the value of the dollar against other currencies currently makes investment in the U.S. extremely attractive. With its dynamic economy, deep capital markets and resilient consumer spending, the United States is likely to remain an irresistible target for foreign companies seeking new business opportunities, yet hurdles remain.

Selecting a Business Location

Good corporate legal strategy in America begins by planning ahead to ensure that, if and when litigation arises, it occurs on favorable terms.  In that regard, the most critical decision a business must make initially is where to locate its headquarters.  There are, of course, a host of issues that must be weighed when choosing where to locate any new business, such as taxes, regulations, access to an educated workforce and whether unions have a strong presence.  However, carefully choosing the location of the principal place of business can go a long way toward minimizing the consequences of litigation by guaranteeing that a forum, friendly to business, hears any future disputes.  Such jurisdictions typically have a negligible union presence and a strong governmental commitment to attracting foreign investment.  The judges are conservative and the juries are well-educated, sensible and stingy.

The Best Defense is a Good Offense

Locating a company in a “pro-business” jurisdiction also allows it to take advantage of the Declaratory Judgment Act (DJA), which authorizes courts to rule on any legal issue presenting an actual controversy between two parties.  Often, a party that wishes to initiate suit will first send the other party a “demand letter” explaining the nature of its legal claim and threatening to sue the other party unless it is paid an outrageous sum of money.

The Benefits of Arbitration over Litigation
To avoid litigation altogether, foreign businesses should also seriously consider including provisions mandating arbitration of any disputes by the American Arbitration Association (AAA) in their contracts.  Arbitration requires the parties to submit disputes to a neutral decision maker and expert in the substantive law, with the authority to issue a binding decision.  The principal advantage of arbitration is that it allows a company to avoid having a jury decide its case.  This can be a real benefit to any corporate defendant, especially when a foreign company faces off against a hometown entity or individual.

The Litigation Process
If all else fails and a company finds itself in court, this need not be cause for despair.  The American judicial system is designed to repeatedly test the merits of the plaintiff’s claims and to dispose of the case at the earliest opportunity.  Indeed, despite its reputation as a no-holds-barred litigious society, only 4.1% of all cases filed in federal court ever reach trial, with the rest being settled by the parties or dismissed by the court. Cases typically begin with the filing of a complaint in court followed by service of the complaint on the defendant.  If the complaint is defective on its face, the defendant may immediately move for dismissal.

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