FDA sends Aurobindo Pharma a Warning Letter over GMP deficiencies cited 8/2021 at its Hyderabad, India-based Unit 1 active pharmaceutical ingredient m...
Mylan Pharmaceuticals recalls one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units/ml, 3mL prefilled pens due to the p...
FDA grants Sensydia a breakthrough device designation for its Cardiac Performance System that measures critical cardiac function.
FDA extends until 2/4 a temporary postponement of certain inspection activities due to the spread of the omicron variant.
FDA launches a REMS Public Dashboard to improve data access and transparency.
Five stakeholders give FDA their recommendations for changes to its proposed rule to establish a regulatory category for OTC hearing aids.
The latest FDA user fee performance report shows the agency met or exceeded many of its FY 2020 PDUFA and BsUFA goals in several different areas of fo...
Under the cloud of an HHS inspector general probe of alleged FDA coziness in the controversial approval of Biogens Alzheimers therapy Aduhelm, CDER Of...