Citing safety concerns, the US Food and Drug Administration (FDA) is updating its guidance to industry on how to properly label injectable drugs for their appropriate doses. The guidance also updates the agency's definition of single- and multiple-dose containers and retires the term "single-use," in favor of the term "single-patient-use," which the agency says will reduce confusion for some products. Single-Patient-Use The introduction of this new term, "single-patien...

Late last month, the US Food and Drug Administration (FDA) unveiled a new proposed rule that many in the pharmaceutical and medical device regulatory communities may have glanced over without a thought because it seemed to pertain only to tobacco products. But on a second look, the rule, if finalized, could have a major impact on the intended use regulations for drugs and devices. For both drugs and devices, an intended use is determined by a manufacturer's expressions, ...

California Gov. Jerry Brown (D) on Sunday vetoed a bill that would've allowed a pharmaceutical company to make an investigational drug available to a patient with a terminal illness on the recommendation of two physicians. Brown explained in a message with his decision that the so-called "Right to Try" (RTT) legislation is intended to help patients with life-threatening conditions, and in some cases these patients can already gain access to experimental treatments under ...

Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies. The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compe...

The European Commission is seeking comment from industry on two documents tied to the guidelines and principles of good manufacturing practices (GMP) for investigational drugs. The commission notes that the current GMPs for medicinal products for human use from a 2003 directive are "generally well-functioning," so, "There is no need to reinvent the wheel." The application of GMPs for investigational drugs is intended to ensure that clinical trial subjects are not p...

In an effort to boost the safety of approved drugs, the European Medicines Agency (EMA) is piloting a new procedure that would allow companies to seek the agency's advice on designing post-authorization safety studies (PASS). Background Currently, EMA and its Scientific Advice Working Party (SAWP) offer scientific advice to companies developing medicines. The advice is primarily intended to help drugmakers design "trials that are scientifically sound and generate rob...

The Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey to gather input on its new draft guidance on the re-manufacturing of single-use devices. Note: at the time of publishing, the survey appears to be closed. According to MHRA's announcement the survey should be available until 1 September 2015. Background In the past, medical devices were typically designed to be reusable and were built to withstand cleaning procedures such...

Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as " Compassionate Use ," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies. This Right to Try Legislation Tracker is meant to be a resource for...

This article explains reasons for reprocessing Single Use Devices (SUDs), major concerns about this practice and the potential impact of these new requirements. For the past several years, the Canadian medical devices industry has opposed reprocessing SUDs strongly, mainly because of unknown safety procedures, although this practice commonly is used in hospitals and by third-party service companies. The Reuse of Single Use Devices Task Force within Canada's medical tec...

Medical devices used in home healthcare settings may soon be made safer thanks to a labeling program being piloted by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). Background In general, medical devices can be divided into two categories: those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers. The latter category,...

In the battle against the Ebola virus, perhaps no weapons have been as sought after as new treatments and diagnostic products to help keep the virus in check and patients safe from harm. But since the start of the outbreak in 2014, one regulatory standard has been an elusive goal for these medical products: Approval. To date, no product has received the full approval of the US Food and Drug Administration (FDA). Now one company is hoping to change that. Seeking Approval ...

A European committee is recommending a series of restrictions on the use of medicines containing codeine in children. PRAC’s Recommendations Citing concerns that codeine can cause breathing problems and other serious adverse effects in children, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is recommending codeine be contraindicated for children less than 12 years of age. Additionally, PRAC says that children between ages 12 ...