60 updates found
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) …
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agenc…
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) …
The Food and Drug Administration (FDA or Agency) has determined that VASOPRESSIN IN SODIUM CHLORIDE (vasopressin) 0.9%, injection, 50 units/50 milliliters (mL)…
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 34 new drug applications (NDAs) from multiple applicants. The applicants notified t…
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) …
The Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber into class II (special controls). The special controls that appl…
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee…
The Food and Drug Administration (FDA, the Agency, or we) is proposing regulations to prescribe the format, content, and procedures for establishment registrat…
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYALEV and is publishing this notice of that determination…
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) …
The Food and Drug Administration (FDA or Agency) has determined that prednisolone tablet, 5 milligrams (mg), was not withdrawn from sale for reasons of safety …
The Food and Drug Administration (FDA, Agency, or we) has determined that RECTIV (nitroglycerin) ointment, 0.4%, was not withdrawn from sale for reasons of saf…
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) …
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agenc…
The Food and Drug Administration (FDA) is classifying the endoscopic traction device into class II (special controls). The special controls that apply to the d…
The Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring device into class II (special controls). The special controls t…
The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.)…
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to direct the public to organizational and contact information available …
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Question…
