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The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. 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
Government auditors last month criticized the FDA for its ongoing drug shortages problem, while House lawmakers chastised the agency at a hearing for not taking more action. Read More
The FDA plans to tell drugmakers by the end of November how they should exchange data with supply chain partners to satisfy new federal track-and-trace requirements. Read More
Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized GMP guidelines. 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 warned China’s CBSCHEM Limited, an active pharmaceutical ingredient (API) labeler, for ignoring fundamental quality functions such as keeping detailed records and maintaining a quality unit. 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
Troubled drug compounder and repackager Medisca has landed in hot water with the FDA again after the agency found a different type of drug in recalled lots of L-citrulline. 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