FDA advances new GMP (good manufacturing practice) rules for PET (positron emission tomography) radiopharma firms
This article was originally published in Clinica
The US FDA is seeking comment on its proposed rule on current good manufacturing practice (GMP) for entities that make the radiopharmaceuticals used for positron emission tomography (PET). The revised preliminary draft proposal incorporates comments FDA received at a 1999 public meeting. Along with the proposed rule, the FDA is also issuing a companion proposed guidance document.
You may also be interested in...
Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.
The maker of prestige-inspired cosmetics at value prices follows its TikTok viral success by teaming with Kathleen Belsten, aka Loserfruit, the second most-followed female gamer on the Amazon-owned livestreaming platform Twitch.
As distribution of Regeneron’s monoclonal antibody treatment for coronavirus begins, OWS officials worry about provider confusion with Lilly’s product due to differences in preparation and administration.