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Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More
House lawmakers advanced an FDA funding package that directs the agency to address a multitude of controversial issues, including justifying the costs to generic drugmakers of the agency’s proposed labeling overhaul. Read More
Eli Lilly said it will begin sharing clinical trial data used in support of regulatory filings in the U.S. and Europe with qualified researchers, becoming the latest drugmaker to join the growing clinical trial data transparency movement. Read More
Delaware has become the latest state to let pharmacists substitute biosimilar products for the prescribed biological reference product, a move cheered by a national trade group representing biopharmaceutical manufacturers. Read More
Injectable drugmaker Hospira has issued a voluntary recall of dobutamine injection, USP, after a customer complaint of discoloration in a single vial of the heart disease drug. Read More
The FDA can exercise flexibility on the quality manufacturing information it requires drugmakers to present under expedited drug approval processes, says a final guidance. Read More
The FDA now has the power to stop any pharmaceutical import it suspects could be adulterated or misbranded, according to a final rule that implements the agency’s new import authority. Read More
The European Medicines Agency is considering new trial designs using pathologic complete response, or pCR, as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early-stage breast cancer. Read More
Australia’s Therapeutic Goods Administration has set a September deadline for companies to adopt a common technical document format for over-the-counter drug submissions. Read More
The U.S. Food and Drug Administration has released a proposed rule allowing it to destroy certain drug imports that have been refused entry into the U.S. — the latest attempt to boost the integrity of the U.S. supply chain. Read More
The European Medicines Agency is urging drugmakers to implement and maintain security procedures for electronic safety-and-acknowledgement messages sent via the internet, and has issued guidance on the technical requirements around online data protection. Read More