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The FDA has released a proposed rule that would allow it to destroy certain drug imports that have been refused admission into the U.S., the agency’s latest attempt to boost the integrity of the U.S. drug supply chain. Read More
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official told DGR. 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
Generic drug giant Teva received FDA clearance Friday to market exclusive versions of Pfizer’s blockbuster arthritis pain drug Celebrex (celecoxib) in the 100 mg, 200 mg and 400 mg capsule forms. Read More
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