We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Drug pricing will be a key healthcare issue for 2018, with state pricing and transparency laws pushing pharma and life science companies to reconsider strategies and business models, according to a new report from the PwC Health Research Institute. Read More
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Read More
In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
The FDA denied a request from Allergan to reject any ANDAs referencing Restasis unless the applicant proves bioequivalence through clinical endpoints. Read More
The Native American tribe that entered a controversial patent deal with Allergan is questioning the impartiality of the Patent Trial and Appeals Board judges charged with reviewing the arrangement. Read More
The FDA’s Office of Prescription Drug Promotion issued just three warning letters and one untitled letter in calendar year 2017 — a record low and down from a high of 156 in 1998. Read More