Final guidance on communication “consistent with the label” is noteworthy for how closely it follows Obama-era draft. That may be a surprising twist given the background of the Trump-era FDA Commissioner and HHS Secretary – but on balance is probably the best possible approach for maintaining the current FDA approval climate.
The US FDA’s decision to finalize a promotional guidance defining a new class of permitted claims that are “consistent with the label” is probably disappointing to some advocates for broad readings of the First Amendment as it applies to drug company communications.
Rather than open up “off-label” promotion entirely, FDA is sticking with the approach crafted in the waning months of the...
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
