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Sponsors planning on sending lot release samples to CBER in May and June should plan to delay until after the center relocates to the FDA’s White Oak headquarters in Silver Spring, Md. Read More
University of Iowa Pharmaceuticals, a contract manufacturer affiliated with the school, received a Form 483 for deficient training materials and poor investigations into quality issues. Read More
The FDA handed distributor and positron emission tomography (PET) drugmaker Cardinal Health a Form 483 for failing to properly verify batch records. Read More
Concerns with particulates in injectable drugs are plaguing Agila Specialties again as the Mylan unit revealed last month that its Polish plant is at the center of a recall of an anesthetic product. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, India’s Central Drugs Standard Control Organization (CDSCO) said last month. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. Read More
A control laboratory testing facility in Mumbai, India, has come under fire from the FDA after a summer inspection last year raised serious concerns about the quality of drugs tested there. Read More
The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
The FDA has selected 13 drugmakers to participate in its Secure Supply Chain Pilot Program, an initiative five years in the making that will grant the companies’ products expedited treatment when they enter the U.S. Read More
The compounding pharmacy lobby is pushing back against the FDA’s campaign to encourage hospitals to buy compounded drugs only from agency-registered sites as disingenuous and misleading, saying the products aren’t necessarily safer for patients. Read More