Cost recovery and the future of the medical device regulation program in Canada.
It is a perennial problem that some government programs seemingly have an abundance of financial capacity while others seem chronically under-funded. Over the years, legislators, ministers, and other government officials have tried a variety of methods to address under-funding. One such method was announced by the Treasury Board on...

Impregnated dressings: drugs or devices?
Introduction This article outlines the main legal and regulatory aspects concerning the registration and reimbursement of drugs and dressings in caring for the diabetic foot in the UK. When inventing or developing a novel product or treatment, it is essential to understand the regulatory system for both...

Agency's approval plan flawed.
FDA is considering new guidance that would allow drug companies to use journal articles to promote "potentially dangerous uses" of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform,...

President Bush proposes about $97 million more for medical product safety, user fees for generics.
FDA is requesting nearly $2.4 billion in the administration's fiscal year 2009 budget--a 5.7% increase over the budget that FDA received for the current fiscal year--the agency announced Feb. 4. The fiscal 2009 request, which covers the period Oct. 1, 2008, through Sept. 30, 2009, includes $1.77...

State lawsuits may proceed against medical device manufacturers.
I. INTRODUCTION II. MEDICAL DEVICE AMENDMENTS III. PREEMPTION IV. FACTS OF LOHR A. District Court B. Eleventh Circuit Court of Appeals C. Supreme Court 1. Negligent Design Claims Under Section 510(k) 2. "Requirement" Under Section 360k(a) 3. Breyer's...

Creepy-crawly care: maggots move into mainstream medicine.
Pamela Mitchell is no stranger to modern medical care. Now 52, the former waitress from Akron, Ohio, began getting regular insulin injections at the age of 10, after she was diagnosed with type 1 diabetes. Twenty years ago, she received a life-saving kidney donation from her brother. In 2001,...

Gender discrimination within the reproductive health care system: Viagra v. birth control.
I. INTRODUCTION Recently, Pfizer Inc. drew nationwide attention by announcing the Federal Drug Administration (hereinafter "FDA") approval of its impotence pill, Viagra. Dubbed as the "magic blue pill," early studies indicate that Viagra enables men diagnosed with impotence to become aroused and engage in sexual intercourse.(2) National...

CardioTech Gets FDA Approval.
HEALTH AND BEAUTY CLOSE-UP-16 July 2008-CardioTech Gets FDA Approval(C)2008 - CloseUpMedia - newsdesk@closeupmedia.com CardioTech International, a developer and manufacturer of advanced biomaterials for a broad range of medical devices, announced that it has received the necessary U.S. Food and Drug Administration (FDA) approval to export its 4mm...

The quandary that is called the FDA.
In the wake of the Vioxx scandal, the Food and Drug Administration has suddenly become the whipping boy of both the press and Congress, a combination that is certainly hard to beat. A feeding frenzy has erupted, with charges coming from inside and outside the agency. I,...

The quandary that is called the FDA.
In the wake of the Vioxx scandal, the Food and Drug Administration has become the whipping boy of the press and Congress. A feeding frenzy has erupted, with charges coming from inside and outside the agency. I, too, have been critical of the FDA at times and...