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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
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites. Read More