Australia, Department of Health and Ageing, Therapeutic Goods Administration (TGA) resource Agency Web Sites Member contributionOCEG Reviewed
The Australian community expects that medicines and medical devices in the marketplace are safe and of high quality, and of a standard at least equal to that of comparable countries.
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Bristol-Myers Squibb : Compliance & Ethics resource Examples Member contributionOCEG Reviewed
The Bristol-Myers Squibb Compliance & Ethics web site. The site contains the following:
Corporate Integrity LLC Advisory and/or Audit Firm
CPSC, Businesses: Report a Potentially Defective or Hazardous Product: Office of Compliance - Section 15(b) Internet Report resource Forms OCEG Reviewed
Manufacturers, importers, distributors, and retailers are required to report to CPSC under Section 15 (b) of the Consumer Product Safety Act (CPSA) within 24 hours of obtaining information which reasonably supports the conclusion that a product does not comply with a safety rule issued under the CPSA, or contains a defect which could create a substantial risk of injury to the public or presents an unreasonable risk of serious injury or death, 15 U.S.C. § 2064(b). The Recall Handbook will familiarize companies with their reporting requirements.
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CPSC, Regulations, Laws & Information for Manufacturers, Importers, Distributors & Retailers resource Agency Web Sites OCEG Reviewed
> Regulations, Laws and Business Information by Product Information on specific products
> Regulations and General Commission Information by Statute (Act) Information on CPSC's laws
> Industry Guidance Recall programs, handbooks, testing manuals and laboratories, and more
> Small Business Information
> Frequently Asked Questions for Manufacturers, Importers, Distributors and Retailers
> Report a potentially defective or hazardous product (Section 15b Report)
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Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, A (2008) resource Articles OCEG Reviewed
Georgetown Law Journal, Vol. 96, 2008
Abstract: This article explores the legality and wisdom of the FDA's effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA's justifications for reversing its long-held views to the contrary and explains why the FDA's position cannot be reconciled with its governing statute.
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CSR And Sustainability: Local Impacts Of Global Supply Chains (2007) resource Articles OCEG Reviewed
To address supply chain problems, companies have implemented supply-chain Corporate Social Responsibility and Sustainability ("CSR") programs. Programs vary, but most incorporate legal, human rights, and environmental principles, describe compliance expectations and supplier compliance obligations, feature inspections to assess compliance, and some explain these efforts to stakeholders.
Cura Software Solutions Technology Provider
Deloitte Advisory and/or Audit Firm
Drugs for Human Use (21 C.F.R. Part 300 et seq.) resource National Regulations OCEG Reviewed
Subchapter D - Federal Regulations on Drugs for Human Use
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