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General Articles
UK NHS Pharmaceutical Approval Body Rejects GSK’s Lupus Drug Benlysta
How is Post-marketing Adverse Event Reporting Done for OTC Drugs?
Lack of Robust Regulations for Generic Drugs Warning Labels Leads to Outcry
FDA Implements Measures to Overcome Drug Shortages – What Manufacturers Should Know
Changes in Labeling Statin Drugs – What the New FDA Draft Guidance Says
Quality Considerations for Demonstrating Bio-similarity to Reference Product – What Does FDA Draft Guidance Say?
Factors to be Considered in Bio-Similar Product Development – Overview of FDA Draft Guidance
FDA’s Draft Guidance on The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k)
Advertising Therapeutic Goods in Australia – Overview of Regulatory Requirements
FDA Fines American Red Cross for Violating Blood Safety Rules
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FDA Issues Draft Guidance for Increasing Women Representation in Medical Device Clinical Trials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
Showing 1 - 50 of 449 Articles | [next]
Compliance Trainings
Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
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How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
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DMR & DHR - What Is Really Required
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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