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Cisplatin, a commonly used chemotherapy drug prescribed to treat several advanced forms of cancer, is again under production by Accord Healthcare, the FDA said Monday. Read More
Our health care delivery system is changing every day. New medicines, innovative research, new reimbursement policies, doctors burning out and retiring, telemedicine, emergency room delays — these and other changes affect us all. Read More
An FDA draft guidance on reporting manufacturing changes in cellular and genetic therapy (CGT) products puts too much emphasis on clinical trials and neglects the benefits and efficacy of bridging studies, according to comments filed by 16 manufacturers and industry. Read More
At first, the idea of repurposing a drug seems so logical. A reasonable person could be forgiven for thinking this is already common practice. Since safety and efficacy have been shown in order to gain FDA approval to use a drug for a specific disease, that logic goes, wouldn’t researchers check to see what other diseases might be treated using such a drug? Read More
In this edition of Quick Notes we tackle regulatory activity across the pond in Britain and the EU with stories on increased EMA fees, electronic product information for medicines, an updated service to help pharmaceutical companies and repurposing of a drug to help prevent breast cancer. Read More
The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections Summit last week. Read More
Quality agreements between companies and third-party vendors should explicitly define key manufacturing roles and responsibilities and establish expectations for communication, such as by providing key contacts for both entities, says a regulatory expert. Read More
Public health officials, patient advocacy groups and health scholars have filed amicus briefs supporting the U.S. government as it fights a lawsuit from AstraZeneca claiming the Inflation Reduction Act’s (IRA)drug pricing negotiation provisions are unconstitutional. Read More
Untitled letters sent to Otsuka Pharmaceutical and Evofem Biosciences alleging false or misleading claims that inflated the effectiveness of the products in direct-to-consumer (DTC) advertising were recently released by the FDA Office of Prescription Drug Promotion (OPDP). Read More