The United Kingdom’s regulatory authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), has appointed a new vice-chair for its Commission on Human Medicines (CHM). Dr. Angela Thomas is taking up the vice-chairmanship from Dr. Ian Weller, who retired from MHRA at the end of 2014, the regulator said in a 19 January 2015 press release. Thomas, a pediatric hematologist, has served as a member of CHM since 2005 and also chairs the commission’s Clinical ...

President Barack Obama's bioethics commission is preparing to weigh in on whether the US Food and Drug Administration (FDA) should require manufacturers of investigational products intended to either treat or prevent the Ebola virus to run clinical trials with placebo controls. Are Placebos Ethical? The issue of placebo controls has been a contentious one to regulators and ethicists around the globe. At issue: Since Ebola has such a high rate of mortality, should all ...

In a major development, the head of the European Medicines Agency (EMA), Guido Rasi, has been forced to step down by the EU Civil Service Tribunal after adjudicators found that the European Commission had improperly selected him in 2011. The case against Rasi's appointment was filed by Emil Hristov, formerly with the Bulgarian Drug Agency and a member of EMA's board, who maintained that EMA and the European Commission had improperly assembled a short list of candidates...

In December 2012, the US Food and Drug Administration's (FDA) drug regulatory body, the Center for Drug Evaluation and Research (CDER), indicated that it wanted to limit the use of some phthalates as excipients in medicines. Now two legislators have a message for the agency: There's more that needs to be done. Background FDA's December 2012 guidance, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products , explained that the agency had foun...

Sponsors of medical device products containing radioactive material may soon find it easier to bring the products to market under a newly proposed rule issued this week by the Nuclear Regulatory Commission (NRC). The rule, Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments , is an update to a 2002 rule on the medical use of so-called "byproduct material." According to the NRC, byproduct materials are tho...

The European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) -a  scientific committee  which conducts risk assessments for EU officials-has announced it is launching an investigation into the safety of transvaginal mesh products used in urogynecologic surgery. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pel...

The European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) -a scientific committee which conducts risk assessments for EU officials-has announced the publication of its initial draft assessment of the safety of metal-on-metal hip implants. Background Metal-on-metal hip implants have been plagued with controversy around the globe. The devices, which claimed to be similar enough to predicate devices made with non-metal parts, have...

The European Commission has released the text of a long-awaited follow-up opinion regarding the safety of breast implants manufactured by the now-defunct Poly Implant Prothese (PIP), a French manufacturer whose products ignited a firestorm of controversy over the safety of medical devices in the EU after they were found to have been manufactured to deficient standards. Background The PIP scandal erupted in late 2011, when regulators determined that the company had bee...

The European Commission has announced that the United States' quality standards are comparable to those of the European Union's, clearing the way for the country's manufacturers to be able to export their active pharmaceutical ingredients (APIs) to the EU without running afoul of the Falsified Medicines Directive (FMD), the terms of which are set to go into effect as of 2 July 2013. Background Under the FMD, also known as Directive 2011/62/EU, all entities importing API...

The European Commission issued final revised Good Distribution Practices (GDP) guidelines  on 8 March 2013 that are designed to incorporate the requirements of a 2011 Directive that targets so-called "falsified medicines" from entering the legal supply chain of the EU.  A draft version of the revised GDPs was issued for public comment (consultation) in July 2011 by the Commission, which noted at the time that the 1994 version of the GDPs was "no longer adequa...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has submitted recommendations to the European Commission to amend the recently implemented EU pharmacovigilance legislation.  In a January 16 letter to the European Commission's Health and Consumers Director General, MHRA recommended changes to patient information that would: Enable patients to get most important information first and then allow them to drill down into more detail as needed....

The European Commission (EC) has launched a public consultation on four revised chapters of its good manufacturing practice guidelines, saying a number of changes were necessary to reflect best practices and the latest thinking. One of the sections set to be revised is GMP Chapter 3 , which details ways in which companies should reduce the potential for cross-contamination in facilities that manufacture multiple product lines. Factories should be designed properly to en...