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A bill overwhelmingly passed by the House to prohibit OTC sales of dozens of steroid precursors would require HHS to evaluate the risks of other dietary supplements that contain substances similar to those listed in the legislation.
The number of adverse events reported to the FDA’s Center for Drug Evaluation and Research (CDER) increased 15 percent last year largely due to electronic filing of adverse event reports, according to the center’s chief.
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the impact of known risks associated with approved drugs without encumbering product availability, according to a draft guidance released last week by the agency.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connection with proposed treatments for which a safe and effective alternative is already in use, according to an FDA draft guidance on risk management released late last week.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and characterize a product's risk profile and to make informed decisions to minimize those risks, the FDA said in a draft guidance released last week.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.
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the impact of known risks associated with approved drugs without encumbering product availability, according to a draft guidance released yesterday by the agency.
The FDA is defending its decision not to allow an agency expert to testify about possible links between the use of some antidepressant drugs and an increased risk of suicide in young people taking the medications.
Lawmakers from the House Energy and Commerce Committee demanded last week the FDA release scores of agency records related to the potential suicide risk posed by antidepressant use among children and whether an agency medical officer was prevented from presenting findings at an advisory committee meeting last month.