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The head of the largest U.S. drug manufacturing trade group is pushing back against critics who claim drug prices are too high, particularly for some new hepatitis C drugs that can cost up to $1,000 per pill. Read More
Indian drugmaker Cadila Healthcare is recalling more than 10,000 bottles of antihistamine due to a drug mix-up, becoming the latest Indian company to face quality problems. Read More
Distributors of active pharmaceutical ingredients in Europe should build quality management systems that include the same features as drugmakers’ QMS in areas such as contamination control and documentation, according to a new reference guide on good distribution practices. 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 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 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