Burgeoning research reaches consumers with information that probiotics help with conditions from irritable bowel syndrome to colds, eczema, constipation and diarrhea. “People absorb that information and then they show up and they buy bugs in a bottle,” says health care marketing consultant Kim Wagner.
Media reports on probiotics research often convey messages on health benefits that the products' marketers would not be allowed to make as health claims on labels or in advertising.
Consumers are receiving messages via media coverage of developing science that probiotics help with conditions from irritable bowel syndrome to colds, eczema, constipation and diarrhea. But manufacturers cannot include that...
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
