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The FDA’s hold on approving Croatian drugmaker Pliva’s drug applications imposed after the agency cited it for current good manufacturing practice (cGMP) violations has been lifted, the company said.
The FDA’s hold on approving Croatian drugmaker Pliva’s drug applications imposed after the agency cited it for current good manufacturing practice (cGMP) violations has been lifted, the company said.
Australia’s Therapeutic Goods Administration (TGA) says certificates issued by the European Community (EC), as well as TGA conformity assessment certificates and mutual recognition agreement certificates, may be submitted as “manufacturers’ evidence” that a medical device has been formally evaluated and that the facility adheres to good manufacturing practices.
Vintage Pharmaceuticals, a generic drug manufacturer, has pleaded guilty to felony charges of distributing adulterated drugs through interstate commerce.
Manufacturing violations cited in a June 15 FDA warning letter to Ranbaxy Laboratories could result in a hold on some of the company’s new drug applications (NDAs) and a U.S. ban on importation of others.
The FDA's efforts to eliminate unapproved drugs from the market are more show than substance and seem to be part of an agency trend to tread lightly where industry is involved, an activist group says.