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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
The court ruled that a brand drugmaker’s payment to settle an infringement case that delays generic competition can support a pay-for-delay claim. Read More
Australian regulators are calling for labels on six types of nonsteroidal anti-inflammatory drugs to include strong warnings about cardiovascular and liver risks associated with excessive or prolonged use. Read More
Pfizer’s novel breast cancer drug Ibrance shows reasonable evidence of clinical benefit to warrant marketing it ahead of a Phase III study, the FDA said in granting accelerated approval Tuesday. Read More
Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols. Read More