‘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.
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'Intended Use' Rule: US FDA May Toss Its 'Totality Of Evidence' Standard
Pharma and device industries had complained that rule is overbroad, violates the First Amendment and would increase company exposure to liability.
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.
Gottlieb Nomination As US FDA Chief Could Signal Changes To Generic Approval Process
Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms.