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The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing a drug shortage. Read More
An industry-funded study suggests that brand drug manufacturers are not taking in as much of the gross drug expenditures than they did in previous years. Read More
The FDA has introduced a new designation for regenerative medicine therapies, laying out the submission requirements for sponsors seeking the expedited review that stems from the 21st Century Cures Act. Read More
The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry. Read More
The FDA plans to require risk evaluation and mitigation strategies for opioid analgesics — including immediate, extended-release and long-acting formulations — to ensure the benefits outweigh the risks of misuse, abuse, addiction, overdose and death. Read More