US FDA Plans Streamlining Infant Formula Approval Process To Expand Supply Chain
FDA “determined a more streamlined pathway” using information it's received for products available under enforcement discretion “would help provide for the long-term availability and marketing of many” of those products.
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APhA, NCPA, APC make clear concerns about shortage of acetaminophen and ibuprofen in liquid formulations and their disappointment with FDA’s response in letter to Center for Drug Evaluation and Research.
FDA “understands that manufacturers expect availability to continue to increase in the near future.” CHPA is working with members “focused on safeguarding the US supply by maximizing capacity to produce and direct product to where it is needed most.”
Shortage began in August and has increased the onset of cough/cold season due to consumers’ “stockpiling/panic buying” in response to high levels of activity in COVID-19, RSV, seasonal flu and other viruses, according to Canadian Pharmacists Association. Health Canada has approved imports of Haleon and J&J children’s pain relievers.