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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 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
Amid controversy over the high cost of its newly approved gene therapy Luxturna — $850,000 before discounts — Spark Therapeutics announced a series of initiatives to improve patient access to the drug, including outcomes-based arrangements with Harvard Pilgrim and Express Scripts. Read More
The Justice Department recovered more than $900 million from medical product manufacturers relating to False Claims Act violations in fiscal 2017, down from $1.2 billion in 2016. Read More
In a move aimed at speeding reviews of generics this year, the FDA released a new draft guidance on ANDAs for public comment along with an updated Manual of Policies and Procedures (MAPP) for agency staff that went into immediate effect. Read More