The FDA is demanding Wockhardt investigate whether management was involved in quality data manipulation at its Chikalthana, India, facility before the agency will lift the import ban it has slapped on the plant. Read More

The FDA Nov. 27 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

Just days after the FDA’s new authorities over compounding pharmacies was signed into law, the agency Monday issued draft guidances detailing how facilities register and report product information to the FDA. Read More

When you greet an FDA investigator, do you ever wonder about his/her qualifications? 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

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 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

US WorldMeds, a specialty drugmaker, has been issued a warning letter from the FDA, noting false claims and omitted risk information for the company’s drug Revonto. 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

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

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