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Regulations & Guidances
FDA Guidance: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
FDA Releases Guidance For Manufacturers on Drug Shortage Notifications
FDA Biosimilars Draft Guidance - Quality Considerations in Demonstrating Biosimilarity to Reference Product
FDA Biosimilars Draft Guidance - Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
FDA Draft Guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
Australia Therapeutic Goods Advertising Code 2007
Australian Anti-Money Laundering and Counter-Terrorism Financing Act 2006
EBA Guidelines on Internal Governance
UK FSA Risk Assessment Framework ARROW
UK Financial Reporting Council Turnbull Guidance - Revised 2004
FDA Draft Guidance on Evaluation of Sex Differences in Medical Device Clinical Studies
Federal Reserve Proposed Rule 2011 - Prudential Standards and Early Remediation Requirements for Covered Companies
EPA Final Rule: Mercury and Air Toxics Standards for Power Plants
Proposed CMS Rule: Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests
Australian Prudential Standard 112 – Capital Adequacy: Standardized Approach to Credit Risk
Australian Prudential Standard 110 – Capital Adequacy
FDA Guidance Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products - Content and Format
FDA Guidance Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products
COREP Reporting Framework - Operational Risk - Template
COREP Reporting Framework - COREP Market Risk - Template
COREP Reporting Framework - Explanatory Notes for Reporting Templates
COREP Reporting Framework - Documentation of Changes - Template
COREP Reporting Framework - Credit Risk - Template
COREP Reporting Framework - Capital Group Solvency Details - Template
FDA Guidance - Medical Device Reporting for Manufacturers
FDA Guidance on Adverse Event Reporting to IRBs - Improving Human Subject Protection
FINRA Proposed Know Your Customer Rule
FDIC Guidance on Safeguarding Customers Against E-Mail and Internet-Related Fraudulent Schemes
Australian Prudential Standard APS 115 Capital Adequacy: Advanced Measurement Approaches to Operational Risk
FDA Draft Guidance on Risk Information in Prescription Drug & Medical Device Ads, Promotional Labeling
PCAOB Staff Audit Alert No 5- Auditor Considerations Regarding Significant Unusual Transactions
Final Rule on Resolution Plans - Federal Reserve Board
FDA Draft Guidance on Human Factors and Usability Engineering to Optimize Medical Device Design
FDA Guidance on Warning and Precautions Labeling for Drugs and Biological Products
Regulation P - PRIVACY OF CONSUMER FINANCIAL INFORMATION
OSHA’s New Laboratory Safety Guidance
Euopean Commission Deposit Guarantee Scheme
Proposed European Capital Requirements Directive, 2011
EU Transparency Directive
International Safe Container Act
Credit CARD Act of 2009
UK Financial Services Authority Guidance on Selling General Insurance Policies on Price Comparison Websites
Section 402 of the FDA Food Safety Modernization Act (FSMA), P.L. 111-353 - Whistleblower Provisions
Section 11(c) of the Occupational Safety and Health Act, 29 U.S.C. §660- Whistleblower Provisions
Corporate and Criminal Fraud Accountability Act
The Secure and Fair Enforcement for Mortgage Licensing or SAFE Act of 2008
Equal Credit Opportunity Act 1974
Basel III Capital Rules
FDA Draft Guidance for Device Industry and Staff for Postmarket Surveillance
FDA 2011 Draft Guidance on Financial Disclosure by Clinical Investigators
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Compliance Trainings
Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
On Demand Access Anytime
How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
On Demand Access Anytime
DMR & DHR - What Is Really Required
On Demand Access Anytime
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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