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.
With the launch of the FDA’s Office of Pharmaceutical Quality, all ANDA filers are now eligible for OPQ’s real-time communications program — the quick-turnaround method the agency will use to resolve minor questions about chemistry, manufacturing and controls during ANDA reviews. Read More
The White House in its fiscal 2016 budget proposal Monday asked Congress to appropriate $486 million for CDER, a bump in funding of less than one percent, and $215 million for CBER, an increase of two percent. Read More
Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
The White House released a joint statement by President Barack Obama and Indian Prime Minister Narenda Modi pledging to negotiate a harmonized approach to intellectual property protections and establish standard definitions for what is patentable. Read More
The House Energy and Commerce Committee’s newly released legislative wish-list for overhauling the FDA and incentivizing new drug development includes few generics-friendly proposals, possibly because the generics industry had little input into the 21st Century Cures initiative that developed the proposals. Read More
Nearly half of all serious adverse event reports submitted to the FDA by drugmakers don’t include basic information such as the patient’s age and gender and the event date, a new analysis of adverse event reports shows. Read More
Japanese regulators have notified Novartis Pharma K.K., the Japanese arm of the Swiss drug giant, that they are planning to temporarily suspend the firm from doing business in the country. Read More
The White House in its fiscal 2016 budget proposal Monday asked Congress to appropriate $486 million for CDER, a bump in funding of less than one percent, and $215 million for CBER, an increase of two percent. Read More
The Delhi high court on Friday set aside a government order rejecting Gilead’s patent for hepatitis C treatment Sovaldi, saying the Office of Patents Designs and Trademark had made procedural errors in issuing its decision. Read More
Japanese regulators are weighing whether the agency will need to begin approving some drugs based on Phase II trial data as they implement approval processes for personalized drug products. Read More