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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
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
The FDA is creating a simple, one-step process for physicians to gain access to experimental drugs for patients facing terminal, untreatable conditions. Read More
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