Tag: Food & Drug Administration
FDA Moves to Ease Nationwide Shortage of Baby Formula
The agency's latest moves should help ease the dire situation many mothers face
Company Hid Problems With COVID-19 Vaccines From FDA
Nearly 400 million doses of vaccine made by Emergent had to be destroyed 'due to poor quality control'
FDA Warns of Counterfeit Home COVID-19 Test Kits
Two fakes the FDA knows of are counterfeit Flowflex COVID-19 test kits and iHealth Antigen Rapid Test Kits
FDA Proposes Ban on Menthol Cigarettes, Flavored Cigars
Research has shown that menthol cigarettes are harder to quit than traditional tobacco products
Moderna Asks FDA to Authorize Its COVID-19 Vaccine for Children Under 6
Preliminary analysis indicates vaccine efficacy of 51 percent among children younger than 2 years and 37 percent among children 2 to 5 years
FDA Warns 12 Companies About Skin Lightening Products
There are no FDA-approved or otherwise legally marketed over-the-counter skin lightening products
Use of Extrapolation Common in FDA New Drug Approvals
Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity
Vijoice Granted First Approval for Treatment of PROS
Real-world data show 27 percent of patients with PIK3CA-related overgrowth spectrum treated with Vijoice had radiological response at 24 weeks
New Law Allows FDA to Police E-Cigarettes Made With Synthetic Nicotine
Vaping companies must now follow the same federal sales restrictions and age requirements as tobacco product companies
FDA Advisers Weigh COVID-19 Booster Shots for Fall
Vaccine experts still guessing at what the ever-changing pandemic will bring
