Compliance Regulations and Guidance Affecting your Industry

This guidance is intended to assist applicants in deciding:

(1) what studies should be included in the CLINICAL STUDIES section of prescription drug labeling,

(2) how to describe individual studies, and

(3) how to present study data, including presentation of data in graphs and tables.

The FDA-prescribed adverse reactions section makes it easier for healthcare practitioners to identify adverse reactions that are most important for prescribing decisions.

Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms.  The EBA has made COREP the standardized reporting framework from 31 December 2012.

This template has to be used when reporting operational risk.

Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms.  The EBA has made COREP the standardized reporting framework from 31 December 2012.

This template has to be used when reporting market risk.

Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms.  The EBA has made COREP the standardized reporting framework from 31 December 2012.

This document explains the terms used in the COREP templates.

Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms.  The EBA has made COREP the standardized reporting framework from 31 December 2012.

This template has to be used when documenting changes.

Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms.  The EBA has made COREP the standardized reporting framework from 31 December 2012.

This template has to be used when reporting credit risk details.

Almost 30 European countries have adopted Common Reporting (COREP), the prudential reporting framework for credit institutions and some investment firms.  The EBA has made COREP the standardized reporting framework from 31 December 2012.

This template has to be used when reporting capital group solvency details.

This guidance document describes the new Medical Device Reporting requirements for manufacturers. It is intended for both domestic and foreign medical device manufacturers, and is based on the Medical Device Reporting (MDR) requirement published in the final rule dated December 11, 1995. The MDR regulation provides a mechanism for FDA to identify and monitor significant adverse events involving medical devices, so that problems may be detected and corrected in a timely manner.

The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects. Institutional Review Board (IRB) reviews and approves the clinical protocol, informed consent forms, study advertisements, and patient brochures.

In general, the new FINRA Know-Your-Customer Rule (2090) requires firms to use “reasonable diligence,” in regard to the opening and maintenance of every account and know the “essential facts” concerning every customer. This rule is modeled after the NYSE Rule 405(1).

The Federal Deposit Insurance Corporation has issued guidance on safeguarding customers against E-mail and Internet-Related Fraudulent Schemes.

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.

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.

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.

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.

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.

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.

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.

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.