Compliance Resources to Help you Stay Current

In late November 2011, Ranbaxy won approval from the FDA to start selling its generic version of Pfizer’s cholesterol drug, Lipitor. The approval was given as Pfizer’s patent for the drug had expired.

This article explains how the FDA approves generic drugs and how Pfizer is trying to lessen the impact of the Lipitor patent expiry.

The spectacular collapse of brokerage firm MF Global in November 2011 and subsequent revelations that millions of dollars of its customers’ money was misused and is missing, spurred the Commodity Futures Trading Commission (CFTC) to finally approve its year old “Client Funds” rule.

This article gives a brief overview of the new rule and how it will affect brokerage firms.
 

Yes – a scanned paper signature is considered an electronic signature as regulations state that an electronic record is considered signed and approved by the signatory if there’s a digital scan of the signature, symbol, digital certificate or corporate logo.

Electronic signatures can be constructed in a number of different ways.

According to the Electronic Signatures in Global and National Commerce (ESIGN) Act, an electronic signature means “an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record.”

For 21 CFR Part 11 compliance, an electronic record is considered signed if there’s a digital scan of the provider’s signature or a digital certificate or a corporate logo – objects which the parties understand is tangible evidence of the signatory’s approval/agreement with the record. The regulation itself states that:

“Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.”

Read the FDA’s guidance to industry on 21 CFR Part 11 compliance

Yes – issuers of money orders and travelers’ checks are specifically required to report transactions that are suspicious and involve or aggregate funds or assets of at least $5000.

A Suspicious Activity Report or SAR is a compliance requirement for financial institutions covered by anti-money laundering laws such as the Bank Secrecy Act. These reports have to be filed with the Financial Crimes Enforcement Network or FinCEN, a bureau under the US Treasury department that enforces anti-money laundering regulations

How do you write an effective Suspicious Activity Report? Read this article to find out.

In November 2007, Australia instituted the Australian Prudential Standard, APS 115 Capital Adequacy: Advanced Measurement Approaches to Operational Risk, under the Banking Act. This standard sets out the requirements that an authorized deposit-taking institution (that has approval to use an advanced measurement approach to operational risk) must meet both at the time of initial implementation and on an ongoing basis for regulatory capital purposes.

This article gives a brief overview and summary of requirements of APS 115.
 

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

This article gives an overview and summary of the recommendations included in the FDA guidance.

In April 2010, the Public Company Accounting Oversight Board (PCAOB) issued a guidance or Staff Practice Audit Alert, Auditor Considerations Regarding Significant Unusual Transactions, aimed at advising auditors on how they should handle significant unusual transactions while auditing a company.

This article gives an overview and summary of recommendations of this guidance.
 

In October 2011, the Federal Reserve Board approved a final rule that will implement the resolution plan requirement, part of the Dodd-Frank Wall Street Reform and Consumer Protection Act. This important financial regulation requires bank holding companies with assets of $50 billion or more and nonbank financial firms designated by the Financial Stability Oversight Council for supervision by the Board to annually submit resolution plans to the Board and the Federal Deposit Insurance Corporation (FDIC). This rule will come into effect from November 30, 2011.

This article gives an overview and summary of requirements of this final rule.
 

The US Federal Reserve Board’s Regulation P or Privacy of Consumer Financial Information (12 CFR 216) regulates the use of nonpublic personal information about consumers by financial institutions.

This article gives a brief overview and summary of Regulation P requirements.
 

In June 2011, the Food and Drug Administration issued draft guidance on using human factors and usability engineering to optimize medical device design. The aim of this guidance document is to help the medical device industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.

This article gives a brief overview and summary of recommendations contained in this draft guidance.
 

In October 2011, the FDA issued final guidance on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drugs and Biological Products. The aim of the guidance is to help ensure that labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

This article gives a brief overview and summary of the recommendations contained in the guidance.
 

On October 13, 2011, OSHA announced the release of a new and revised Laboratory Safety Guidance document aimed at protecting lab workers from exposure to chemical, biological and physical hazards.

This article gives an overview of this new guidance document and its requirements.

In 1994 the European Commission issued a Directive on Deposit Guarantee Schemes that aimed at protecting bank account holders in case of banks failing. After the 2008 financial crisis, the EU member states decided to increase the level of deposit protection and new Deposit Guarantee Scheme requirements were implemented and became effective in 2010.

This article gives an overview and summary of requirements of the Commission’s Directive on Deposit Guarantee Schemes.
 

In July 2011, the European Commission modified its Capital Requirements Directive to strengthen the stability of European banks. Rules under this proposed directive, known as CRD IV, is expected to be in place by the end of 2012 and banks across the EU are expected to comply by 2019.

This article gives a brief overview and summary of requirements of the Commission’s proposed Capital Requirements Directive.
 

The European Union’s Transparency Directive or TD was implemented to harmonize the transparency requirements for information about issuers whose securities are admitted to trading on a regulated market.

This article gives a brief overview and summary of requirements of the EU’s Transparency Directive.
 

The European Commission announced on October 20, 2011 that it has proposed modifications to its Markets in Financial Instruments Directive or Mifid to clamp down on high frequency trading and uncontrolled and non-transparent commodity speculation that is blamed for recent stock market volatility.

This article gives a brief overview of the proposed changes to Mifid and what the Commission hopes to achieve.
 

The Electronic Funds Transfer Act, enacted into law in 1978, was implemented as Regulation E by the Federal Reserve Board and aimed to protect consumers using electronic funds transfer services. The Act established the basic rights, responsibilities and responsibilities of consumers using electronic services to transfer funds and those of financial institutions providing these services.

The new Consumer Financial Protection Bureau (CFPB), a consumer agency formed by the 2010 Dodd Frank Act, announced on October 13, 2011 that it would increase its oversight of the mortgage servicing industry.

This article gives an overview of what the CFPB hopes to achieve by increasing its scrutiny of the mortgage servicing industry.
 

The International Safe Container Act, Chapter 805 of Title 46 of the CFR, details the requirements for application and compliance with the International Convention for Safe Containers signed in 1972 in Geneva. The Act also gives the requirements for approval, examination and enforcement of these requirements. It also contains whistleblower protections. It was enacted into law in 1977.

This article gives an overview and summary of the International Safe Container Act.

The Credit Card Accountability Responsibility and Disclosure Act or Credit CARD Act of 2009 was enacted into law by President Obama. The aim of the Act is stated to be to “amend the Truth in Lending Act to establish fair and transparent practices relating to the extension of credit under an open end consumer credit plan.” It was intended to comprehensively reform how credit card companies charge card holders.

This article gives a brief overview and summary of provisions of the Credit CARD Act.