Researchers say “an optimal dose of PE that is safe and produces clinically significant decongestion is still unknown,” and advocates for removing phenylephrine from the OTC monograph say their study is the proof FDA requested.
Researchers suggest FDA remove phenylephrine from the OTC drug monograph after their study found the ingredient, in doses up to 40mg every four hours, is no more effective than a placebo in alleviating nasal congestion from seasonal allergic rhinitis.
The study authors, led by Eli Meltzer, of the Allergy and Asthma Medical Group and Research Center in San Diego, say their research shows “an optimal dose of PE that is safe and
Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.
A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
