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The FDA issued a final rule May 10 designating the immunomagnetic circulating cancer cell (CCC) selection and enumeration system as a Class II device with special controls.
The Generic Pharmaceutical Association (GPhA) wants the FDA to add regulatory language that would expressly require a brand firm to correct or delete patent information in the agency's Orange Book when a court order requires patent changes.
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the impact of known risks associated with approved drugs without encumbering product availability, according to a draft guidance released last week by the agency.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connection with proposed treatments for which a safe and effective alternative is already in use, according to an FDA draft guidance on risk management released late last week.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and characterize a product's risk profile and to make informed decisions to minimize those risks, the FDA said in a draft guidance released last week.
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.
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the impact of known risks associated with approved drugs without encumbering product availability, according to a draft guidance released yesterday by the agency.
Once a drug is on the market, collecting safety data and assessing risks based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions to minimize those risks, the FDA said in a draft guidance released yesterday.