The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced that four National Health Service hospitals have agreed to pilot a new tracking system for high risk medical devices.  The goal of the tracking system, one of 11 projects established by the agency in response to the Poly Implant Prothèse silicone breast implant issue, is to improve the monitoring of medical devices such as breast implants, heart valves and pacemakers. The new...

US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a series of tools required of some drugs by the US Food and Drug Administration (FDA) to control the potential risks associated with use of a drug product. Background REMS were first introduced under the 2007 FDA Amendments Act (FDAAA) , and were meant to act as a regula...

Benefit:risk (B:R) assessment is a critical step in the process of approving a drug and in re-assessing an already marketed drug, in the case of newly identified important safety signals. B:R assessment is a holistic process that requires data from different sources to be reviewed to reach a decision on whether a drug's benefits outweigh its risks. 1 Due to the heterogeneity of the data under review (e.g., toxicological, efficacy and safety), all previous approaches usin...

The US Food and Drug Administration (FDA) has published a new report calling for a new drug regulatory decision-making paradigm for risk-benefit assessments, rejecting calls for a quantitative-only approach to regulation as counterproductive to its goals to make the decision-making process as clear and predictable as possible. Background The plan, published on 5 March 2013, notes that FDA's mission calls for it to approve drugs that are both safe and effective. But the ...

A new report just published by the Department of Health and Human Services (DHHS) claims that the US Food and Drug Administration (FDA) lacks sufficient data to determine whether one of its flagship postmarketing safety methods, Risk Evaluation and Mitigation Strategies (REMS), is actually effective at ensuring product safety. Background REMS plans were instituted in 2007 under the FDA Amendments Act , and were seen as a response to a number of product safety scandal...

Chapter 15 Pharmacovigilance has been defined by the World Health Organization as, "The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem." 1 Pharmacovigilance (or risk management) should help to inform both healthcare professionals and patients, allowing them to make educated decisions when choosing a treatment. 2 The main methods for pharmacovigilance are randomized trials,...

High-risk medical devices will no longer be eligible for mutual recognition of conformity assessment with the European Union (EU) as of 1 January 2013, according to the amended Mutual Recognition Agreement (MRA) concluded between Australia and the EU. All Class III-high risk-medical devices are excluded from the MRA until the appropriate confidence building activities have been undertaken between the two parties. Also excluded from the amended MRA are certain medical ...

Patients and physicians alike often have lofty expectations and aspirations about the effectiveness of a prospective treatment. But, as a new article in the Annals of Family Medicine argues, those expectations contribute significantly to both the increasing costs of healthcare and avoidable harms suffered by patients. At the core of the healthcare cost crisis right now is an unavoidable fact, writes Steven Woolf, MD: The cost of obtaining healthcare, and in particular ...

The US Food and Drug Administration's (FDA) Drug Safety and Risk Management Advisory Committee (DSaRM) is preparing to meet in December to discuss risk management strategies for teratogenic products. Teratogens are most commonly pharmaceutical products which, when taken by a pregnant woman, can cause birth defects or other developmental abnormalities. One of the most notorious teratogens is Thalidomide, a drug used briefly in the 1950s and 60s to treat the effects of mor...

The European Medicines Agency (EMA) has announced the start of an investigation into Roche Registration-the EU subsidiary of Roche-after UK regulators conducting an inspection found, "Serious shortcomings" in the company's pharmacovigilance processes. The investigation could be the first major test of the EU's recently passed pharmacovigilance legislation. EMA has previously blasted the company in a June 2012 statement regarding the same incident, saying the company ...

A new discussion paper generated by three of the EU's top scientific committee has called for a paradigm shift in the way regulators assess risks to human health from a hazard-driven process to one driven by exposure. The paper, Addressing the New Challenges for Risk Assessment , was issued by three of the European Commission's Scientific Committees: the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), the Scientific Committee on Consumer ...

An advisory committee meeting convened on behalf of the US Food and Drug Administration (FDA) is set to discuss factors influencing the communication concerning regulated healthcare products, including pharmaceuticals, medical devices and biologics, FDA announced in the Federal Register . FDA's Risk Communication Advisory Committee (RCAC) is set to meet on 2 November 2012 to discuss the topic of message fatigue, warning fatigue and "inaccurate risk perception," all ...