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PubMedDate not supplied

The legal significance of clinical engineering certification.

Recent court decisions and legislation have initiated a new period in product liability--one in which the traditional concepts of liability are being broadened to include, for example, X-ray treatment as a product that, if defectively administered, could result in liability to someone associated with its transmission, regardless of fault. In addition, there has been a successful attempt at holding an entire industry, as opposed to an individual person or company, responsible for an alleged defective product. Clinical engineers should consider whether licensure, registration, or certification would provide additional protection against litigation. The legal significance of such moves would vary from state to state. Professional certification, unlike registration or licensure, would not subject a clinical engineer to increased governmental control.

Biomedical Engineering↗
PubMed1995

Law and medicine.

The constitutionality of criminal prohibitions on physician-assisted death has become one of the most fascinating issues. The Supreme Court viewed a judicial injunction enforcing access to an abortion clinic as "content neutral" and not subject to heightened scrutiny under the First Amendment.

Abortion, Induced↗
PubMed2002

Challenges associated with the evaluation of veterinary product bioequivalence: an AAVPT perspective.

The Generic Animal Drug Patent Term Restoration Act (GADPTRA) enacted in 1988 provided the same benefits to animal drug products that were granted to human generic products. It has been over 13 years since the GADPTRA was enacted, and veterinary drug sponsors and regulators have gained enormous insight and experience into some of the unique challenges associated with the determination of product bioequivalence for veterinary dosage forms. Moreover, advances in information and technology have opened both new issues that must be addressed and new mechanisms for demonstrating product bioequivalence. While many aspects of the existing Center for Veterinary Medicine Bioequivalence Guidance continue to provide invaluable guidance to the animal drug industry, there are also aspects of this guidance that are being called into question. Therefore, during the 2001 annual meeting of the American Academy of Veterinary Pharmacology and Therapeutics, participants were asked to address issues and concerns associated with the evaluation of veterinary product bioequivalence. This manuscript provides a summary of the concerns and discussions that transpired.

Animals↗