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.
The International Council for Harmonization has identified the key scientific issues pediatric drug developers must address early on to improve the prospects for a drug’s approval later in the development process, in a draft that updates a 16-year-old efficacy guideline. Read More
The FDA will release biosimilar interchangeability guidelines on schedule by the end of the year, CDER Director Janet Woodcock confirmed yesterday. Read More
A congressman wants answers on why a pharmaceutical company has increased the price of a medication used to treat lead poisoning in Flint, Mich., the latest in a string of challenges by legislators to drug company pricing. Read More
The European Medicines Agency has begun publishing clinical study data for all new drug applications submitted after Jan. 1, 2015, regardless of approval status. Read More
Draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments on the draft. Read More
Industry groups have backed the FDA’s commitment goals for GDUFA II, bringing the user fee program closer to reauthorization after Friday’s public meeting. Read More