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BI subsidiary Ben Venue is recalling a lot of acetylcysteine 10 percent USP, after a single glass particle was seen in a single vial of the drug. 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 Thursday. 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
Drugmakers should be careful not to use language in product labeling that could be considered promotional, such as comparisons with an alternate treatment, a Health Canada final guidance says. Read More
An updated Health Canada guidance on quality information drugmakers must submit with marketing applications includes harmonized references on how to document a quality-by-design approach during drug development. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has released a guide for drugmakers on how to differentiate between defects, errors and adverse drug reactions and what to do when quality defects are suspected. Read More
Government auditors Feb. 10 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