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Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation Nov. 18 that instead allows compounders to volunteer for agency oversight. Read More
Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More
In the wake of record-breaking numbers of drug shortages, particularly generic injectables, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is advising drugmakers to establish a drug shortage task force. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
A North Carolina pharmacy is recalling all of its sterile compounded drugs distributed within the Tar Heel State and ceasing production of sterile products altogether after an FDA site inspection. Read More
The FDA has handed Daiichi Sankyo an untitled letter for making claims in a brochure that two of its hypertension treatments helped lower blood pressure in patients with severe hypertension, despite a lack of substantial supportive evidence. Read More
A panel of FDA advisors Nov. 14 overwhelmingly voted against approval of Sanofi’s Lemtrada for an expanded indication to treat relapsing multiple sclerosis (MS). Read More
The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More
More than three years after Hospira’s Rocky Mount, N.C., plant was warned for lax quality control, prompting a painful manufacturing slowdown and a costly remediation, the drugmaker expects to near the “top end” of production capability in 2014, Hospira’s chief said Nov. 6. Read More
The FDA has handed specialty drugmaker US WorldMeds an untitled letter for omitting key risk information and making unproven claims on its website about its drug Revonto. Read More
The FDA is requesting that certain OTC topical antiseptic drugs be repackaged with updated labeling to decrease the risk of infection resulting from their improper use. Read More