FDA clears a Civco Radiotherapy 510(k) for its Solstice SRS Immobilization System.
CBER sends an untitled letter to the operator of two Web sites http://www.ollereg.com and http://www.innovativeallergy.com because they were promoti...
As part of its continuing push to modernize clinical trials, FDA posts two guidance documents to provide greater clarity and recommendation for drug d...
Presumably to avert new FDA regulations about adding price information in direct-to-consumer ads, Pharmaceutical Research and Manufacturers of America...
FDA approves EyePoint Pharmaceuticals Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uveitis affecting the po...
FDA Review posts the Federal Register notices for the week ending 10/12/2018.
FDA posts a guidance entitled Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.