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.
During clinical development, biosimilars makers can request as many meetings with FDA reviewers as necessary but they need to be outcomes-based with a priority on narrowly defined questions that the FDA can answer. Read More
The Department of Justice, the FDA and other federal partners announced a nationwide sweep that resulted in the filing of criminal and civil cases against 89 makers of dietary supplements. Read More
The majority of the Senate Committee on Health, Education, Labor and Pensions, from both sides of the aisle, supported Robert Califf’s nomination as the next FDA commissioner Tuesday. Read More
The board of directors of Brazil’s Anvisa has suspended the deadline for companies to submit data for a new drug tracking system and is repealing the system’s implementing legislation. Read More
Some of the world’s poorest nations have been granted an extended exemption from enforcing pharmaceutical patent protections by a World Trade Organization body overseeing intellectual property rights. Read More
To beef up scrutiny of drugs, India’s health ministry has proposed a roughly U.S. $277 million plan to overhaul the Central Drugs Standard Control Organization — by strengthening the inspections framework, establishing new national testing laboratories and firming up databases of products and clinical trials. Read More