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General Articles
EBA Guidelines on Internal Governance – Overview and Summary of Requirements
Are Internal Stress Tests Mandatory Under Proposed Federal Reserve Prudential Standards?
Do All US Banks have to Comply with New Fed Reserve Early Remediation Rules?
Would Medical Device Clinical Studies be Judged Gender-Biased if Sponsors Use Women-Focused Communication Strategies?
New Fed Reserve Rules Require US Bank Holding Companies to Conduct Stress Tests, Early Remediation
FDA Issues Draft Guidance for Increasing Women Representation in Medical Device Clinical Trials
Are OTC drugs covered by CMS’ proposed Physician Payment Sunshine rule?
Will Drug, Device and Biologics Manufacturers be Penalized for Not Reporting Payments Under the Proposed CMS Rule?
Do the new EPA Mercury and Air Toxics Standards Apply to All Electric Utility Steam Generating Units?
EPA Issues First Standards for Mercury and Air Toxics Pollution from Power Plants
Physician Payment Sunshine Act 2010 Proposed Rule Published – Overview and Summary of Requirements
Does a Medical Device Manufacturer Have to Report All Malfunctions of a Device?
Can the US Government Overrule the FDA’s Approval for a Drug?
Australian Prudential Standard 112 – Requirements for Capital Adequacy against Credit Risk Exposures
Australian Prudential Standard 110 – Capital Adequacy Requirements for Deposit Taking Institutions
Will the CFTC Client Funds Rule Allow Brokers to Invest Client Funds in US Treasuries?
Does the ANDA process require manufacturers to do extensive clinical research?
FDA Approves Ranbaxy’s Lipitor Generic – How Does the Agency Approve Generic Drugs?
How MF Global Collapse Pushed CFTC to Approve Client Funds Rule
Will a Scanned Paper Signature be Considered an Electronic Signature?
Do Money Order & Travelers’ Check Issuers Have to Comply with Suspicious Activity Report (SAR) Requirements?
Australian Prudential Standard APS 115 Capital Adequacy: Advanced Measurement Approaches to Operational Risk – Overview and Summary of Requirements
Risk Information in Prescription Drug & Medical Device Ads, Promotional Labeling – What the FDA Expects
PCAOB Advises Auditors on Handling Significant Unusual Transactions
Bank Holding Companies with $50 billion Assets to Submit Annual Resolution Plans to FDIC, Fed Reserve
Federal Reserve Board Regulation P – Privacy of Consumer Financial Information – Overview & Summary of Requirements
FDA Issues Draft Guidance on Human Factors and Usability Engineering to Optimize Medical Device Design
FDA Issues Guidance on Warning and Precautions Labeling for Drugs and Biological Products
OSHA’s New Laboratory Safety Guidance – Overview and Summary of Requirements
European Commission Deposit Guarantee Schemes – Overview and Summary of Requirements
European Commission’s Proposed Capital Requirements Directive – Overview and Summary of Requirements
EU Transparency Directive – Overview and Summary of Requirements
EU Proposes Measures to Clamp Down on High Frequency Trading
Regulation E – Electronic Funds Transfer Act – Overview and Summary of Requirements
Consumer Financial Protection Bureau to Increase Oversight of Mortgage Servicing Industry
International Safe Container Act – Overview and Summary of Requirements
Credit CARD Act of 2009 – Overview and Summary of Provisions
UK Financial Services Authority Issues Guidance on Selling General Insurance Policies on Price Comparison Websites
Whistleblower Provisions in Food Safety Modernization Act (FSMA) – Overview and Summary
Whistleblower Provisions in the Occupational Safety and Health Act – Overview and Summary
Corporate and Criminal Fraud Accountability Act – Overview and Summary of Requirements
Equal Credit Opportunity Act – Overview and Summary of Requirements
Secure and Fair Enforcement for Mortgage Licensing (SAFE) Act – Overview and Summary of Requirements
Basel III – An Overview of the New Global Regulatory Standard
EU Regulation on Food Additives, Flavors and Enzymes - Overview and Summary of Requirements
FDA Launches New System to Respond to Foodborne Illness Outbreaks
FDA Issues Draft Guidance for Device Industry and Staff for Postmarket Surveillance – Overview and Summary of Recommendations
FDA’s New Import Screening Tool PREDICT – Overview and Current Status
IEC 62304 – Medical Device Software Life Cycle Process Standard – Overview and Summary of Requirements for Software Development
Regulators Weaken Dodd-Frank Draft Regs, Allow More Risk
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Contributing Authors/ Experts
Michael Anisfeld,
Senior Consultant, Globepharm Consulting Inc.
Sonia Gourary,
, PQC Consulting Inc.
R. Wayne Frost,
President, Frost Biopharmaceutical Consulting
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