In a recent letter to drug firms, FDA rejects Plan B One-Step manufacturer Teva’s requests to restrict sales and labeling of generic equivalents. Labeling for the generics will not prevent consumers under 17 from buying the products nor require retailers to ask consumers for proof of age.
FDA will allow OTC sales of private-label versions of Teva Pharmaceutical Industries Ltd.’s emergency contraceptive Plan B One-Step without label restrictions that Teva proposed for the generic equivalents.
The agency’s Center for Drug Evaluation and Research says it will accept labeling for private label versions of Plan B One-Step (levonorgestrel 1
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.
The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.
Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.
Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.
Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.
During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.
