We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
An Arizona company marketing an unapproved vaginal contraceptive cream has settled a federal complaint and agreed to stop distributing the product until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Read More
The FDA has published 40 new and revised product-specific guidances (PSG) which provide recommendations for developing generic drugs and generating evidence to support ANDA approvals. Read More
A groundbreaking treatment for sickle-cell disease and transfusion-dependent β-thalassemia using the biomedical advancement of CRISPR technology has been authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for patients aged 12 and over. Read More
The manufacturer of eye drops linked to more than 80 adverse reactions, including 14 cases of blindness and four deaths, received a 15-page FDA warning letter calling the company out for lack of product sterility as well as inadequate product formulation, data integrity lapses and more. Read More
IQVIA, the global contract research organization juggernaut, has filed its opposition to the FTC’s proposed preliminary injunction halting its acquisition of Propel Media, the latest in its back and forth with the federal regulator over the latter’s fears surrounding consolidation in the digital healthcare advertising market. Read More
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An FDA draft guidance on reporting manufacturing changes in cellular and genetic therapy (CGT) products puts too much emphasis on clinical trials and neglects the benefits and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