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The European Medicines Agency is asking drug companies to keep pharmacogenomics in mind when doing pre- and postauthorization safety assessments, noting that the selection of biomarkers is key to maintaining a robust safety profile as part of pharmacovigilance activities. Read More
FDA advisors want stronger warning language on labels for non-steroidal anti-inflammatory drugs, or NSAIDs, saying language added in 2005 is not strong enough and may lead doctors and patients to think there is no risk of cardiovascular (CV) blood clots in short term use of the drugs. Read More
Government auditors Monday criticized the FDA for its ongoing drug shortages problem, while House lawmakers chastised the agency at a hearing for not taking more action. Read More
Merck has agreed to pay $100 million to settle thousands of liability claims alleging the drugmaker’s NuvaRing contraceptive causes potentially fatal venous thromboembolisms. Read More
The Centers for Medicare and Medicaid Services (CMS) has relaxed the deadline for submitting 2013 data under the Physician Payment Sunshine Act, giving drugmakers until late spring to report the details of payment information. Read More
Days after the FDA said it plans to investigate the safety of testosterone replacement drugs, Abbott was hit with five lawsuits claiming the drugmaker marketed Androgel to millions of men who didn’t need it and hid the risks of heart attack and stroke associated with the drug. Read More
FDA Commissioner Margaret Hamburg took the unusual step Thursday of publicly defending the agency’s expedited drug approval pathways in the face of growing criticisms, which now include a congressional inquiry into the FDA’s approval standards. Read More
House lawmakers have proposed legislation that would restrict the bulk distribution and use of dextromethorphan (DXM) in finished drugs in a bid to help curb adolescent abuse of OTC cold and cough medicines. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More