PubMed Health⌕ Search
Home/Archive/PubMed

PubMed · 15255536

Beyond the US submisson process.

Maria Donawa
View original source ↗Export metadata ↓

Abstract

After expending considerable effort to comply with United States (US) marketing authorisation regulations, a company launched its first product on the US market. Unfortunately, the company failed to comply with other applicable US regulations, which led to a delay in the US product introduction and FDA postmarketing enforcement actions against the product. This article discusses ways that companies can prevent this from happening.

Explore related subjects

CommerceConsumer Product SafetyDevice ApprovalEquipment and SuppliesGuidelines as TopicProduct LabelingProduct Surveillance, PostmarketingRadiation ProtectionUnited StatesJournal Article

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

Maria Donawa. 2004. Beyond the US submisson process.. https://pubmed.ncbi.nlm.nih.gov/15255536/

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed2007

ACOG Committee Opinion No. 359: commercial enterprises in medical practice.

Increasing numbers of physicians sell and promote both medical and nonmedical products as part of their practices. Physicians always have rendered advice and treatment for a fee, and this practice is appropriate. It is unethical under most circumstances, however, for physicians to sell or promote medical or nonmedical products or services for their financial benefit. The following activities are considered unethical: sale of prescription drugs to be used at home, sale or promotion of nonprescription medicine, sale or promotion of presumptively therapeutic agents that generally are not accepted as part of standard medical practice, sale or promotion of non-health-related items, recruitment of patients or other health care professionals into multilevel marketing arrangements, and sale or promotion of any product in whose sale the physician has a significant financial interest. It is ethical and appropriate, however, to sell products to patients as follows: sale of devices or drugs that require professional administration in the office setting; sale of therapeutic agents, when no other facilities can provide them at reasonable convenience and at reasonable cost; sale of products that clearly are external to the patient-physician relationship, when such a sale would be considered appropriate in an external relationship; and sale of low-cost products for the benefit of community organizations. A rationale is provided for both the prohibited activities and exceptions.

Commerce↗