FDA: Patients Should Be Cautious When Using Online Pharmacies to Buy Meds
Red flags include pharmacies that do not require a doctor’s prescription or have a licensed pharmacist to answer questions
Red flags include pharmacies that do not require a doctor’s prescription or have a licensed pharmacist to answer questions
For patients who tolerated and remained on therapy, the average treatment effect on serum phosphorus was about -0.7mg/dL.
The agency has issued proposed draft recommendations to guide incorporation of cybersecurity protections into medical devices at the time of manufacture.
The source of the chemicals is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines.
Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity
The NDA submission included data from 36 clinical trials involving over 8000 patients.
No improvement seen in representation of Black patients after implementation of a 2015 FDA action plan to improve diversity
Condom was approved through the De Novo premarket review pathway for low- to moderate-risk devices of a new type
Findings from an ongoing randomized, placebo-controlled, observer-blind phase 3 trial showed Spikevax was 93.2% effective at preventing COVID-19.
Throat swabs are common in some countries, but most self-tests in the United States require nasal samples