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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
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 last month. Read More
Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation that instead allows compounders to volunteer for agency oversight. Read More
Drugmakers have 13 months to revamp how they track drugs after President Barack Obama signed into law a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
The FDA Tuesday hit Wockhardt with a second “import alert,” banning drug products from its Chikalthana plant in western India — the latest in a spate of regulatory actions taken against the struggling drugmaker. Read More
President Barack Obama Wednesday signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More
President Barack Obama Nov. 27 signed into law a bill that establishes both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary FDA oversight of compounding pharmacies. Read More
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Nov. 25 it is relaxing those restrictions in line with its advisers’ recommendations. Read More
The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming. Read More
While advances in technology have improved the purity profile of urokinase-based drugs, EU regulators are urging makers of these drugs to estimate the risk that an individual dose of a product might be contaminated with pathogens. 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
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