Manufacturers need to provide two-week updates on any supply issues during the COVID-19 emergency and going forward, the FDA said in a new straight-to-final guidance.
Also, companies should notify the agency as soon as possible, but no later than five business days after discontinuation of a drug or a manufacturing issue arises, the guidance says.
Ideally, though, drugmakers should contact the FDA at least six months in advance when they decide to stop manufacturing and distributing a product or if they encounter manufacturing issues that will likely lead to a “meaningful disruption” in supply, the agency said.
In the guidance, the agency says the new recommendations apply to any interruptions or discontinuances for drug products that are “life supporting, life sustaining,” including drugs used in emergency medical care and surgery.
Read the full final guidance here: www.fdanews.com/03-30-20-Guidance.pdf. — James Miessler