Biopharma Wins Reprieve On US FDA 'Intended Use' Rule
In response to MIWG petition, agency delays by one year implementation of final rule on what activity is considered evidence of a manufacturer's intended use of a product.
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Off-Label Communications: Near-Term ‘Seismic Shift’ In FDA Oversight Unlikely
It’s not realistic to expect sudden changes in US agency’s regulation of medical product communications to healthcare providers and payers given the other pressing issues facing new Commissioner Scott Gottlieb, Medical Information Working Group’s Klasmeier says.
‘Intended Use’ Rule: Industry Urges US FDA To Revoke ‘Totality Of Evidence’ Standard
Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.
First Amendment Does Not Block Off-Label Enforcement Actions, FDA Reiterates
Agency memo on manufacturer communications about unapproved uses says new court rulings and studies on off-label uses and adverse reactions support restrictions; whether agency’s new leadership has the same view remains to be seen.