[ Price : $8.95]
FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.[ Price : $8.95]
SunMed Holdings recalls its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter.[ Price : $8.95]
Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies growing use of direct-to-consumer telehealth platform...[ Price : $8.95]
FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women i...[ Price : $8.95]
FDA rejects Genentechs bid to broaden the use of its lymphoma drug Columvi.[ Price : $8.95]
FDAs Psychopharmacologic Drugs Advisory Committee votes against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when us...[ Price : $8.95]
An HHS official says FDA is taking a hard look at pulling from the market Sarepta Therapeutics gene therapy Elevidys (deland...[ Price : $8.95]
An online post details a significant number of resignations from CDER in the first six months of this year.