The 21st Century Cures Act has been in the news again this week, as lawmakers have decided to remove a controversial provision in the Bill, that would have nullified current requirements for reporting payments, made by companies, to doctors, for receiving medical education sessions and materials ...Read More
Temperature-controlled comparator drugs used in clinical trials can be difficult to transport from the manufacturer to the clinical trial site. A trial sponsor must carefully plan and manage the transportation process in order to ensure the drugs stay within their specified temperature range ...Read More
For some sick patients, receiving medication through an Expanded Access Program (EAP), also known as managed access, compassionate use, named patient, etc., is the only viable treatment option left. These programs allow the patients to gain access to investigational new drugs which are still in the clinical trial phase and are not, yet, licensed for use ...Read More
Specialty pharmaceuticals, which once occupied a very small niche in the market, are fast becoming a critical growth segment in drug development. In fact, in 2012, around 65% of spending on new drugs was dedicated to specialty pharmaceutical products, according to a report from IMS Health ...Read More
The FDA has awarded $23 million to 21 industry and academic groups to help fund research into a range of rare diseases. The grants were awarded through the FDA’s Orphan Products Clinical Trials Grants Programs and will be used over the next four years. ...Read More
Generic drugs have long been advertised as cost-effective alternatives to expensive brand name drugs. But it seems even generic drug manufacturers have joined the bandwagon, in recent years, when it comes to racking up drug prices and charging patients absurd amounts of money. ...Read More
Right to Try laws are becoming increasingly common in states across the US. The first was introduced in Colorado in 2014, and, since then, 31 states have followed. But what exactly is a Right to Try law, and why have so many state governments chosen to enact this new legislation? ...Read More
Reference listed drugs (RLDs) play a crucial role in generic drug development. According to the US Food and Drug Administration (FDA) regulations, generic drugs must replicate the RLD by having; the same main active ingredient, the same strength and dosage form, the same route of administration and intended use, and bioequivalence to the RLD. ...Read More
After more than a year of negotiations with the generic drug industry, the Food and Drug Administration (FDA) has recently released the draft performance goals and program enhancements for the Generic Drug User Fee Act for FYs 2018-2022 (GDUFA II). ...Read More