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Home » Topics » Pharmaceuticals » GMPs

GMPs
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FDA Requests Nominations for Do-Not-Compound List

December 3, 2013
The FDA is building a list of difficult-to-manufacture drugs that compounders will not be allowed to make and is soliciting public suggestions for products to place on the list. Read More

FDA Wants Wockhardt Management Audited in Quality Data Probe

December 3, 2013
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

Second FDA Import Ban Increases Wockhardt’s Regulatory Hurdles

December 3, 2013
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

FDA Rolls Out Compounding Regulation, Seeks More Inspection Funding

December 2, 2013
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

No Two FDA Investigators Are Alike

December 2, 2013
When you greet an FDA investigator, do you ever wonder about his/her qualifications? Read More

Industry Groups Slam Short Deadline for EU GMP Regs

December 2, 2013
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

Beleaguered Wockhardt’s Regulatory Hurdles Increase With Second FDA Import Ban

November 27, 2013
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 Signs Track-and-Trace, Compounding Bill

November 27, 2013
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

FDA Raps US WorldMeds for Unsupported Treatment Claims

November 22, 2013
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

Industry Groups Slam Short Deadline for GMP Requirements

November 22, 2013
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

Industry Groups Slam Short Deadline for Cross Contamination GMP Regs

November 21, 2013
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

Senate Passes Pharmaceutical Track-and-Trace Legislation

November 20, 2013
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
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