What Not To Do When FDA Comes Knocking
This article was originally published in PharmAsia News
The U.S. FDA tweaks final guidance on what constitutes interference with FDA inspections to include examples of ‘reasonable’ explanations for sponsor delays; industry had requested many other changes.
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Sterile areas, cell therapies, and security systems are just a few of the items where industry wants FDA inspector access limited without triggering a new law that would make products in a facility deemed adulterated.
FDA has a powerful new tool to assure access to drug manufacturing plants: legislated authority to deem a product adulterated when a company tries to evade inspections: A new guidance elaborates on the situations that FDA will define as obstructionist, and cuts into new territory by defining refusal to provide records in lieu of an inspection as an actionable offence.
Seeking To Provide ‘The Best Clarity Possible,’ ACIP Votes For COVID Vaccine Booster In Children 5-11
CDC advisory committee recommends Pfizer/BioNTech vaccine booster, but one member votes ‘no,’ citing concern that only 29% of children ages 5 to 11 have received the primary two-dose series and arguing the focus should be on additional vaccinations, not additional doses.