Data integrity lapses raised in FDA warning letter to California analytical testing lab shows that such issues are not confined to Asia and that FDA will, in fact, challenge US facilities to show they are managing their quality data properly.
FDA Aug. 2 issued a data integrity-focused warning letter to a California testing laboratory after it had failed for more than three years to turn on audit trails in testing equipment and give analysts their own passwords.
The warning letter, issued by the agency's Los Angeles District Office, proves that US facilities are not exempt from the...
Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.
The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.
Europe’s research-based pharma industry group, EFPIA, is pressing EU policymakers to protect innovative medicines after the EU-US trade deal confirmed a 15% tariff on pharmaceutical exports. Generic products, meanwhile, have secured an exemption.
The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.
ISRCTN says its new system for reporting clinical trial results summaries will simplify compliance, and includes features to reduce data entry errors, improve accuracy, enhance accessibility and the reuse of trial results.
Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.
The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.
