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Drugmakers, who have been waiting quite some time for the FDA to provide them with the agency’s thinking on the issue of risk management, got at least some relief earlier this month. The agency issued three draft guidances — titled “Premarketing Risk Assessment,” “Development and Use of Risk Minimization Action Plans” and “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment” — that address many of the industry’s questions about how to navigate the tricky regulatory waters of risk management. While the documents may not be as complete as some in the industry would have liked them to be, they do describe safety issues throughout a product’s life cycle, including development, review, approval and market availability. In addition to the three guidances, the FDA also has released a pharmacovigilance guidance drafted by the International Conference on Harmonisation that outlines ways drugmakers can summarize the identified risks of a drug, the potential for unidentified risks, as well as possible risks for specific populations and situations that have not been studied preapproval. Taken together, the four documents represent a regulatory roadmap of the FDA’s latest thinking on the issue of risk management.
The FDA's Center for Biologics Evaluation and Research (CBER) plans this year to develop a template for reviewing proposed products, implement a formal training program for reviewers and create more opportunities for biotech firms and other stakeholders to provide input on efforts to enhance the development of new products.
Just one week after its final rule banning dietary supplements containing ephedra took effect, the FDA settled the cross hairs of its regulatory sights firmly on the rest of the supplement industry, saying it will employ a risk-benefit test it has never used with supplements to more closely monitor the products and vigorously pursue enforcement actions against those it considers unsafe.
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characterizing a product's risk profile and for making informed decisions to minimize those risks, the FDA said in a draft guidance released earlier this month.
Acknowledging that risk management is an increasingly important area, drugmakers are welcoming the FDA’s new draft guidances on the issue, noting the documents will help them better understand the agency’s expectations in a field becoming increasingly critical 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 earlier this month by the agency.
When assessing the risks of an investigational drug, drugmakers may need to build larger safety databases, 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 earlier this month.
The FDA earlier this month released three long-awaited draft guidances to help drug manufacturers achieve more benefits from drug and biologic products while minimizing their risks, following up on the concept papers the agency issued last spring.
The FDA should test different models of the brief summaries drugmakers are required to include in their direct-to-consumer advertising in order to see which version consumers would be more likely to read and understand, the Federal Trade Commission (FTC) says.
The nation's second-largest manufacturer of private-label OTC products was recently issued an FDA warning letter documenting more than a dozen deviations from current good manufacturing practice (cGMP) regulations.