Aurora Pharmaceutical is pleased to announce the availability of EquiCoxib, the FDA-approved generic equivalent of Equioxx® (firocoxib), a... Feb 13, 2025, 09:29 ETFDA GRANTS FAST TRACK DESIGNATION TO PLEOPHARMA, INC's INVESTIGATIONAL NEW DRUG, PP-01, FOR THE MITIGATION OF CANNABIS WITH...
nor did you have data to support that your test method was equivalent or better than the USP method.In your response, you state that you will revise your (
Former White House strategic communications director Mercedes Schlapp and podcast host Monica Crowley weigh in on record-high inflation and the baby formula shortage on 'Kudlow.' More than half a million cans of baby formula from Australia will make its way into the U.S. this summer as the F...
nor did you have data to support that your test method was equivalent or better than the USP method.In your response, you state that you will revise your (
Canadian, Mexican, Brazilian, European and Asian regulations are not similar or equivalent. Why would you take a chance? Whereas the United States has always relied on a strictly centralized process through one agency, the Food and Drug Administration (FDA), the European Commission synchronized the...
If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If conco...
According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry. ...
conducting sterile compounding activities, reducing sterile compounding activities in consideration of the risks and need for the compounded product, and, if applicable, using other PPE that confers equivalent or better protection for the compounded product as outlined in FD...
assisting the FDA in communications with your company; responding to questions concerning your imported products sold in the US; assisting the FDA in scheduling inspections of your facilities. The FDA may also provide information or documents to your US agent, which is considered equivalent to prov...
Advertising itself as zero sugar and vegan, the neon-colored cans are among a growing number of energy drinks with elevated levels of caffeine; in PRIME’s case, 200 milligrams per 12 ounces, equivalent to about half a dozen Coke cans or nearly two Red Bulls. ...