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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 FDA will create a pharma-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More
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