[ Price : $8.95]
Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) introduce Making Objective Drug Evidence Revisions for New(MODERN) Labeling ...[ Price : $8.95]
FDA clears a de novo request to permit the marketing of Adaptive Biotechnologies ClonoSEQ assay, a next-generation sequencing-base...[ Price : $8.95]
FDA releases a final guidance entitled Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, ...[ Price : $8.95]
FDA asks pen needle manufacturers to add a label Warning regarding proper use of the devices.[ Price : $8.95]
FDA releases the FDA-483 with two observations from a September inspection at the Sun Pharmaceutical facility in Punjab, India.[ Price : $8.95]
FDA releases the FDA-483 with three observations from an inspection at Indias Stride Pharma Science.[ Price : $8.95]
FDA grants HighTide Therapeutics a fast track designation for its investigational new drug, HTD1801, for treating patients with pr...[ Price : $8.95]
CDRH chief medical officer William Maisel reaffirms the agencys intention to modernize its Quality System regulation for medical d...