Healthcare Reform bill:US

March 23, 2010

Salient features of the Healthcare Reform bill

For the first time, most Americans would be required to purchase insurance, and face penalties if they refused.

  • Bill was expansion of coverage to 32 million Americans who are currently uninsured.
  • Bill will also weaken the grip of health insurance companies over the market by preventing them from denying coverage based on pre-existing conditions and restrict their ability to raise premiums or drop coverage.
  • Children may remain on their parents’ insurance policies until the age of 26 and insurance companies would no longer be able to impose lifetime limits on policies. The costs of obtaining insurance cover would also fall for older people and those with pre-existing conditions through their participation in “high-risk pools.”
  • Small business would also derive such benefits by participating in state-level exchanges and some businesses would face penalties for not providing their employees with insurance.
  • The bill, which will soon be signed into law by President Obama as the Patient Protection and Affordable Care Act, will also bring down the deficit of the country by $143 billion over 10 years and by over a trillion dollars within the following 10 years, according to the Congressional Budget Office (CBO).
  • It will cost the American taxpayer $940 billion, according to the CBO.
  • Coverage would be required for incomes up to 133 percent of the federal poverty level, $29,327 a year for a family of four.
  • Childless adults would be covered for the first time, starting in 2014.
  • The insurance industry, which spent millions on advertising trying to block the bill, would come under new federal regulation.


FDA Issues 22 Warning Letters to Web site Operators

December 1, 2009

FDA’s Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers.


None of the Web sites are for pharmacies in the United States or Canada.

What did the agency issued?

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law.

Guidelines for Secure Use of Social Media by Federal Departments and Agencies, v1.0

November 30, 2009


Federal Government information systems are targeted by persistent, pervasive, aggressive threats.

In order to defend against rapidly evolving social media threats, departments and agencies should include a multi-layered approach in a risk management program, including risks to the individual, risks to the department or agency, and risks to the federal infrastructure.

Social media technologies such as Wikis, Blogs, and social networks are vulnerable to the following methods/techniques of cyber attacks: Spear phishing, Social Engineering, and Web Application Attacks

The Threat

Federal Government information systems are targeted by persistent, pervasive, aggressive threats. This is well known and documented, as stated in May of 2009 by Margaret Graves, Acting CIO for the Department of Homeland Security.


The following are a series of strategies and recommendations for federal departments, agencies, and policy makers to minimize risk.

Policy Controls

The safe use of social media is fundamentally a behavioral issue, not a technology issue.

Policy addressing behavior associated with protecting data would likely cover current social media technologies as well as future technologies. Policies for Web 2.0 technologies, blogs, wikis, social media sites, mash-ups, cloud computing, Web 3.0, outsourced e-mail, and other new technologies will remain extensible and applicable.

Acquisition Controls

When Federal agencies use hosted information systems, such as social media websites, they must have some level of risk management, mitigation, and acceptance of residual risk.

Most social media websites have a service subscription model that provides additional capabilities, or may be able to provide federal agencies with additional capabilities for a fee. This has already been demonstrated through modifications to Terms of Service (TOS) agreements by GSA.

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies

October 27, 2009

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

The draft guidance for industry titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications”:

  • provides FDA’s current thinking on the format and content that industry should use for submissions of proposed REMS
  • describes each potential element
  • includes preliminary information on the content of assessments and proposed modifications of approved REMS
  • describes REMS policies for certain regulatory situations
  • informs industry about who to contact within FDA about a REMS
  • indicates FDA Web sites where documents about approved REMS will be posted
  • provides an example of what an approved REMS might look like for a fictitious product.

Check out for draft guidance at –

Companies meet deadline to file financial data in new format

September 24, 2009

In January 2009, SEC finalized a rule requiring public companies to use extensible business reporting language, or XBRL, to submit financial information to the agency’s public financial reporting Web site, EDGAR.

During first phase of the three-year process included more than 425 public companies with a worldwide public common equity float in excess of $5 billion.

By 2011, between 10,000 and 12,000 companies are expected to submit statements in XBRL.


FDA Issues Final Regulation on Dental Amalgam

July 30, 2009

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

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Quality System Inspection Technique (QSIT) :FDA

June 18, 2009

According to the FDA, 30% of the 10 most frequent observations in Form 483s issued for QSIT inspections are related to CAPA, and 50%  are CAPA-related for non-QSIT inspections.

See webinars which can help device makers to ensure quality standards

  1. CAPA – The Heart of Your Quality System
  2. CAPA systems in Post Marketing Surveillance
  3. Root Cause Analysis for CAPA Management (Shutting Down the Alligator Farm
  4. How CAPA and complaint handling should interact in Medical Device – Simplification of the processes is often needed to preserve their effectiveness
  5. Preparation of a corrective action/preventive action plan (CAPA) in Drug Safety/Pharmacovigilanc