Data integrity warning letter to Chinese API maker reflects continuing focus of FDA enforcement efforts on the pharmaceutical industry's Asian supply chain.
FDA Aug. 2 posted yet another warning letter to an Asian active pharmaceutical manufacturer over data integrity issues.
In recent months, there has been a flurry of such warning letters to Indian API makers, but the attention appears...
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The Drug Regulatory Authority of Pakistan has adopted a new benchmark for good manufacturing practices, ensuring that the quality and safety of medicines produced in Pakistan meet international standards.
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.
Compliance deadline comes three months after manufacturers were required to start sending accurate, electronic product tracking data to distributors. The Healthcare Distribution Alliance said its members are ready and it does not anticipate major supply chain issues.
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.
