FDA evolves application process

July 15, 2008

The US Food and Drug Administration (FDA) is continuing to evolve in the face of current challenges through the launch of two new initiatives.

Firstly the agency has called time on its “approvable” and “not approvable” responses to drug applications, replacing it with a “complete response”.
This brings the approval response into line with biologic license applications. The “complete response” will detail specific flaws in the application and recommendations as to how to achieve approval.
Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research (CDER), said: “These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form.
Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent.”
A desire not to scare investors has been cited as a reason for the change. According to financial website Motley Fool the old system was “hated by most investors” as it gave too broad a definition, giving little idea of how close to approval a drug was.
Implementation of the new letters is due to occur on August 11. The FDA documentation on the change can be found here.

FDA launches electronic drug registration

The FDA has initiated a voluntary pilot programme enabling pharmaceutical manufacturers to electronically file drug establishment registration and listing information.
By implementing electronic registration the FDA believes it can make “significant improvements in the timeliness and accuracy of the information received“.

In addition, the FDA has said new system will create a more accurate bank of information. The agency believes this will improve its ability to identify possible safety issues and respond to emergencies such as drug recalls and shortages.

Electronic filing will be initially rolled out on a voluntary basis, with the FDA planning on ending the transition period on June 1 2009. After this date all filings must be made electronically.
Guidance has been issued by the FDA to smooth the transition for manufacturers. The relevant documents can be found here and here.


Why you shouldn’t lie on your CV

July 15, 2008

This is something which each of us should learn why we shouldn’t lie on you CV . Never look for short term benefits.

Tata Consultancy Services, TCS, India’s largest software exporter, recently asked nearly 20 employees to leave the company’s Kolkata centre after the company realised that their resumes were manipulated.

Its not in present that companies across the sectors have asked there employees to leave but in the past, India’s top notch companies belonging to high-growth sectors like the IT, ITeS, BPO, banking, financial services, and insurance began the practice of verifying employees’ background by hiring background verification companies like FirstAdvantage and Integrascreen.

As per FirstAdvantage, out of two million resumes that they screened in 2006-07 for discrepancies, a whopping 30 per cent were fudged. In the same year Infosys too had asked 100 employees to leave because of fudged resumes.

Now the question comes in mind why companies do the recheck so here is answer:

Reasons for background checks

Security concerns:

The above-mentioned situations are some of the more extreme instances that have made most organisations sit up and be more careful about the kind of people they hire. Security is a serious concern — be it about that of the employees or clients’ confidential data or that of the company itself. Increasingly, companies, particularly those in the IT sector are investing more in securing their intellectual property and confidential data that can influence their bottom line.

Negligent hiring:

Organisations are also wary of hiring employees who could lead to loss of face in the industry by unwanted lawsuits spurred on by misconduct, especially at senior levels. Cases of the top brass indulging in personal or professional transgressions cause severe embarrassment and loss of credibility in the market. A background check conducted before the final offer can help filter out candidates who have a reputation of personal or professional misdemeanor.

Incorrect or ‘padded’ information:

Organisations are wary of candidates who seek jobs based on fake experience certificates, ‘padded’ resumes and portfolios. Although most HR managers have local contacts and it is easy to casually ‘find out’ about a potential candidate, this is not a foolproof solution of a correct hire. These days, using the services of a neutral third party or companies conducting background checks for various organisations are on the rise.

What does a background check involve?

Although background verification is not an ‘investigation’, it can cover a substantial part of your working life. At most, previous employers confirm the duration of employment, designation and profile, compensation, and other limited information about the employee.

Background checks may also be conducted if the organisation has reason to suspect that an employee might have been asked to leave their previous jobs.

There have been numerous instances where employees were asked to leave when the information they have shared with the prospective employer has been found to be fraudulent.

More often than not, employers validate information about the following:

  • Past employers
  • Education qualifications
  • Personal references
  • Criminal records
  • Drug test records

Source: Rediff


IFRS and When

July 15, 2008

The SEC may decide soon whether and when U.S. companies will switch to international accounting standards. And it’s a good thing, as panic from not knowing the date is percolating.

The curtain has risen, the band is playing — but when, precisely, will international financial reporting standards (IFRS) take center stage?

That’s the question on the minds of companies, academics, audit firms, and virtually every other entity remotely connected with corporate finance. There is growing speculation that the Securities and Exchange Commission will set a date as early as mid-August, which many say is not a moment too soon.
The move from generally accepted accounting principles (GAAP) to IFRS not only seems to be a foregone conclusion but also appears to have been fast-tracked. Last month, Financial Accounting Standards Board member George Batavik said that several key FASB projects, including lease accounting, financial-statement presentation, and revenue-recognition guidelines, have undergone “dramatic scope change” — that is, a reduction — to ensure that they can be completed by 2011.

Many experts now believe that what was once billed as a “convergence” of U.S. GAAP and IFRS has become essentially a switch to the latter, with 2013 whispered as the likely implementation date.

Given the scope of anticipated changes, that date has touched off a keen sense of urgency. Sue Haka, president-elect of the American Accounting Association and a Michigan State University accounting professor, points out that the number of accounting instructors is dwindling even as the number of accounting majors increases. The availability of textbooks and changes to accounting exams are also key issues affected by a date for IFRS adoption, as is the retraining challenge that audit firms will confront.

And, of course, companies of all sizes will face the same challenge in extremis. “I just can’t imagine the amount of money that’s going to be spent retraining everybody,” says Larry Levine, head of business valuation and corporate finance at RSM McGladrey. “Everybody who touches finance and accounting is going to have to have some kind of reeducation and training.”

Is that a clock ticking, or something more ominous?

Click here to listen webinars on SEC, SOX and Banking and finance related compliance.

Source: CFO.com


Ranbaxy refutes DoJ’s adulteration charges

July 15, 2008

Indian drugmaker Ranbaxy Laboratories has refuted the charges levelled against it by the US Department of Justice (DOJ) of not sharing audit information sought by the US authorities to investigate the allegations of document forgery and sale of substandard drugs in the US market.

In an eight-page response filed with the district court of Maryland (US), a copy of which is with ET, Ranbaxy said the DoJ’s legal move was not consistent with the department’s ordinary practice in such investigations, adding that it has already informed the US government of the company’s willingness to share the remaining records sought by them.

“Since Ranbaxy became aware of the investigation it has cooperated fully. The government already has hundreds of thousands of pages of Ranbaxy documents, and as a result of previous privilege waivers and non-assertions of privileges, the government already has over one hundred thousand pages of PAREXEL documents.

While Ranbaxy believes that some of the work done by PAREXEL, are protected by attorney client and work product privileges, Ranbaxy had already informed the government at the time of this motion was filed that it had waived its privileges for all audits conducted by PAREXEL and as a result, and is not now or at the time the motion was filed any dispute requiring adjucdication of the court,” the company said in its reply to the court.

It added that PAREXEL conducted two separate audits in 2006 for stability verification and quality system improvement program of the Paonta Sahib plant. It shared the two documents with the FDA in 2006.

After DOJ conducted raids at its US facilities in 2007, Ranbaxy said that while it was willing to share additional information which the government investigators wanted and told the authorities in July that PAREXEL had done several audits for the company.

DOJ requested the company to produce all the PAREXEL audits. However, in September 2007, DOJ served PAREXEL subpoena for all audits and underlying papers. “Ranbaxy argued to both FDA and DOJ that the government’s request for voluntary audits conducted at the request of the counsel was bad policy,” the paper said.

Ranbaxy said that on July 3, within half an hour of first call from the government counsel informing Ranbaxy of the motion to compel, the company informed the government that it would waive privilege for the remaining audits. At the time this motion was file, it was moot, Ranbaxy said.

In a motion filed at the district court of Maryland on July 3, the DoJ has said there was evidence to suggest that Ranbaxy used active pharmaceutical ingredients (API) from unapproved sources, blended unapproved API with approved API, and used less-than-approved API at its Paonta Sahib (Himachal Pradesh) plant in its drugs, resulting in the sale of ‘subpotent, super potent or adulterated medicines’ in the US market.

The DoJ also said contrary to the stipulation of manufacturers using approved sites, evidence suggests that Ranbaxy manufactures products at other plants and obtains API from unapproved sources.

Source: Economic Times