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.
Long-awaited guidance on designating a biosimilar as interchangeable with the reference product may soon be in the offing, based on an FDA request for comments on a proposed collection of information. Read More
Interested parties will soon get another crack at submitting comments on the FDA’s highly controversial proposed rule that would give generics makers authority to update their labels independently – authority only brandmakers currently have. Read More
Drugmakers claiming a product is protected by a patent will need to make much more detailed justifications of their claims under a new rule proposed by the FDA Thursday. Read More
UK regulators shut down a plant in Cambridgeshire that was producing an unapproved and unlicensed product used against diseases such as HIV and cancer. Read More
After serving as FDA commissioner for six years, Margaret Hamburg has resigned, ending a tenure during which the agency boosted its focus on drugs for unmet needs, strengthened policing of compounding pharmacies and increased drug approvals. Read More