FDA and HHS announced a series of actions intended to phase out the use of petroleum-based synthetic food dyes. The news ...

Short Summary The EU, UK, and USA each have distinct and evolving regulatory systems for medicines and medical devices, involving strict approval, surveillance, and market access requirements managed ...

The FDA first promulgated a definition of “healthy” in 1994 ... DV stands for daily value. For mixed foods [21 CFR § 101.65(d)(3)(iii)] – meaning foods composed of elements from more than one food ...

This guidance provides the agency’s current thinking on establishing a routine sanitation program for low-moisture, ready-to-eat foods that can help prevent pathogen contamination events and also sets ...

The Food and Drug Administration (FDA or Agency) has determined that MOBIC (meloxicam) tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This ...

The average cost of car insurance for a 21-year-old is $302 per month for a full coverage policy and $220 per month for minimum liability insurance. Full coverage car insurance for a 21-year-old ...

Marks is highly regarded by former FDA leaders and biotech industry executives, but his time at the agency was not without controversy. During the COVID-19 pandemic he was alternately criticized ...

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some ...

Dosing starts at once every two months and is based on the FDA-cleared INNOVANCE Antithrombin companion diagnostic test (Siemens). Fixed dosing of Qfitlia is not approved due to excessive clotting ...

SCGP agents are subject to the general conditions in 50 CFR parts 13 and 21, and conditions specified in paragraph (d) of the ODWC’s SCGP, and the conditions outlined below. SCGP designated agents ...