A panel of advisors says that the agency should loosen restrictions on the sale of a diabetes drug with a spotty clinical safety record.
A panel of advisors says that the agency should loosen restrictions on the sale of a diabetes drug with a spotty clinical safety record.
After numerous high-profile safety scares, clinicians and regulators push to fix critical weaknesses in the FDA’s monitoring system for approved drugs.
Patient safety is paramount in regulating new stem cell treatments.
Doctors question whether a government initiative to speed approval for promising new drugs is ensuring safety.
A consumer advocacy group calls for a ban of a diabetes drug after evidence surfaces that it may increase the risk of cancer.
The US regulatory agency recalled 54 percent more drugs from the second to third quarters of 2011.
Pharmacovigilance must keep pace with global distribution of drugs in resource-limited settings.
Europe’s anti-fraud office has launched an investigation into potential conflicts of interest at the EU’s drug approval agency.
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