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.
The FDA’s Division of Drug Marketing, Advertising and Communication (DDMAC) has issued a warning letter to Janssen Pharmaceutica regarding a “Dear Healthcare Provider” (DHP) letter that included misleading claims about the company’s atypical antipsychotic drug Risperdal.
Drugmakers that implement detailed, proactive risk management action plans (RiskMAPs) can minimize the impact of known risks associated with approved drugs without encumbering product availability, according to a draft guidance released last week by the agency.
Drugmakers may need to build larger safety databases when assessing the risks of an investigational drug, especially in connection with proposed treatments for which a safe and effective alternative is already in use, according to an FDA draft guidance on risk management released late last week.
After a drug has entered the marketplace, it is critical for manufacturers to collect safety data and assess risk based on observational data in order to evaluate and characterize a product's risk profile and to make informed decisions to minimize those risks, the FDA said in a draft guidance released last week.
Higher average clinical research and development (R&D) costs for drugs in some therapeutic classes are helping create an incentive for drugmakers to shift their efforts among disease states, according to a new study by the Tufts Center for the Study of Drug Development (CSDD).
The FDA last week issued three draft guidances to help drug manufacturers achieve more benefits from drug and biologic development processes while minimizing their risks, as a follow-up to the concept papers it released last spring.
The FDA has released three question-and-answer guidances to assist drugmakers with efforts to comply with key International Conference on Harmonisation (ICH) initiatives.
Drugmakers are welcoming the FDA’s new draft guidances on risk management strategies, noting the documents will help them better understand the agency’s expectations in an increasingly important area for the pharmaceutical industry.
Two dietary supplement manufacturers have sued the FDA in a federal court over the agency’s final rule banning products that contain ephedrine alkaloids.
The FDA envisions the pipeline of combination products moving from the typical current effort to improve the safety, efficacy or ease of use of a drug, device or biologic to a future in which combination products would pursue two or more separate therapeutic benefits.