Compliance Resources to Help you Stay Current

The UK Financial Services Authority or FSA, which regulates the banking, financial services and insurance industry in the country, issued new guidance on selling general insurance policies on price comparison websites.

This article gives a summary and overview of the guidance.

The Food Safety Modernization Act (FSMA) of 2011 not only formulated regulations to protect consumers by ensuring safety in the manufacture and production of food, but also includes statutes to protect employees who turn whistleblowers.

This article gives a brief overview and summary of these provisions.
 

The Occupational Safety and Health (OSH) Act provides protection against retaliation based on an employee's exercising a variety of rights guaranteed under the Act, such as filing a safety and health complaint with OSHA, participating in an inspection, and so on.

This article gives a brief overview and summary of the whistleblower provisions in the OSH Act.
 

Sections 801 to 807 of the Sarbanes Oxley Act of 2002 are known collectively as the Corporate and Criminal Fraud Accountability Act. The Act details criminal penalties for securities fraud and protects employees-turned-whistleblower of publicly traded companies from retaliatory actions by their employers.

This article gives an overview and summary of requirements of the Corporate and Criminal Fraud Accountability Act.

The Equal Credit Opportunity Act was a consumer protection legislation enacted in 1974, which aims to give all bona fide, legal individuals the opportunity to apply for loans from banks and other financial institutions. The Act makes it illegal to discriminate against any individual on grounds that don’t directly relate to their creditworthiness.

This article gives an overview and summary of requirements of the Equal Credit Opportunity Act.

The Secure and Fair Enforcement for Mortgage Licensing or SAFE Act of 2008 was formulated in order to reduce fraud and regulatory burden and increase consumer safety with regard to mortgages. It regulates the license and registration of mortgage loan originators.

This article gives an overview and summary of requirements of the SAFE Act.

In September 2010, global banking regulators issued new rules that required banks to increase their capital reserves in order to avoid calamitous situations that unfolded after the financial crisis in 2007.

This package deal is known as Basel III. This article summarizes the requirements of this new global regulatory standard

The regulatory agencies in charge of finalizing some of the most controversial rules mandated by the financial reform law are leaning toward making them looser and more favorable to banks and other traders, according to recent reports in the financial press.

This article gives details of the proposed changes.

The Securities and Exchange Commission yesterday unveiled proposed rules to ban hedge funds and banks from assembling risky securities, marketing them to investors and then immediately betting against their own creations, reaping profits when they fail. The rule would also ban firms from setting up risky securities for the benefit of an undisclosed third party.

This article gives details of the proposed rules.

Under European legislation, food additives must be authorized before they can be used in foods. In December 2008, a new regulatory package on Food Improvement Agents was adopted.

This article gives an overview and summary of requirements of the EU's regulations on additives, enzymes and flavorings.

On September 14, the FDA announced that it was creating a new, streamlined and integrated system to effectively and rapidly respond to human and animal foodborne illness outbreaks. The agency has named the system as the FDA Coordinated Outbreak Response and Evaluation (CORE) Network.

This article gives details about this new FDA initiative.

On August 16, 2011, the FDA issued draft guidance for the medical device industry and its own staff on how to conduct postmarket surveillance. This new guidance, when it is finalized, is expected to supersede the guidelines issued in 2006.

This article gives an overview of the new guidance and recommendations.

The FDA will soon be implementing a new import screening tool, Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT. This system is expected to improve the current electronic screening system by targeting higher risk products and minimizing delays in shipping lower risk products.

This article gives a brief overview of the PREDICT tool and recent developments in its implementation.

The IEC 62304 is a global harmonized standard adopted by the US and EU. It gives life cycle requirements for medical device software as well as medical software.

This article gives an overview of the standard and a summary of the IEC 62304 requirements for software development.

The FDA released draft guidance in May 2011 to assist clinical investigators, industry and FDA staff in interpreting and complying with regulations governing financial disclosures by clinical investigators, 21 CFR Part 54.

This article gives an overview of the recommendations included in the draft guidance. Comments on these draft guidelines were due by July 25, 2011.

In August, the Financial Industry Regulatory Authority (FINRA) issued further guidance on how social networking websites should be used for business communication. FINRA had earlier, in January 2010, published an initial guidance document on the same subject but felt the need to clarify its rules following questions posed by business.

This article gives an overview of this new guidance issued by the authority.

California’s strict environmental regulations – the most stringent and complex in the US – also extend to hazardous waste management and disposal. While the state follows requirements of the federal Resource Conservation and Recovery Act, it also has additional state-specific regulations laid down in Title 22, California Code of Regulations.

This article describes how California’s hazardous waste regulations classify different types of waste and the regulatory requirements that apply to generators.

As medical devices become increasingly available for home use and more use-accessible and friendly, it has become important for manufacturers to ensure the product’s quality, safety and reliability. Medical device quality regulatory requirements issued and enforced by agencies such as the FDA act as a valuable guide for manufacturers.

This article gives a brief overview of the FDA’s medical device quality system regulations.

An Exxon Mobil Corp. refinery in Baton Rouge, Louisiana was cited for OSHA violations by the Labor Department, specifically alleging that it exposed workers to fire hazards.

This article gives a brief overview of the alleged violations, proposed penalties and response to them.

Following good laboratory practices (GLPs) is necessary to ensure that quality is maintained and results are accurate. In this article, Marcelle Cortezia, an expert on pharma manufacturing and quality processes, gives practical tips on the following GLP areas:

• General Laboratory Practices and Test Procedures
• Laboratory Documentation
• Laboratory Training and Personnel Certification