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The Indian government is offering a reward to whistleblowers who provide information leading to the seizure of spurious, adulterated and misbranded drugs. Read More
After asking drugmakers in 2011 to voluntarily withdraw pain medications containing more than 325 milligrams of acetaminophen over safety issues, the FDA has pulled the remaining ANDAs from firms that either failed to submit sufficient data with their withdrawal applications or didn’t submit an application at all. Read More
Brand manufacturer Mayne Pharma and Warner Chilcott, U.S. marketer of Mayne’s acne drug Doryx, have moved to settle class action claims with third party purchasers that allege the two companies inappropriately delayed generic competition on the product. Read More
Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates. Read More
Compounding pharmacy JCB Laboratories has been hit with an FDA warning letter for failing to properly package and store vials of the powerful anesthetic Propoven. Read More
The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More
Sponsors designing trials involving certain vulnerable patient populations such as limited or non-English speakers, dementia or traumatic brain injury sufferers and children will soon face greater scrutiny from institutional review boards under newly issued FDA guidance. Read More
The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data. Read More