Tag: Food & Drug Administration
10 Percent of New Drugs Approved Without Meeting Primary Efficacy End Points
Findings seen for 21 drug approvals between 2018 and 2021, with only one-third needing postmarketing studies
After Baby Formula Scandal, FDA Announces New Unit Focused on Food Safety
Agency will also create a new Center for Excellence in Nutrition to better inform Americans about the nutritional value of everyday foods
FDA Says No to Regulating CBD Products as Supplements
How to regulate CBD supplements has become a pressing public health concern as the popularity of CBD supplements has exploded in the United States
Updated Booster Shots, Not Original COVID-19 Vaccines, Should Be Standard: FDA Panel
Committee members also weighed a proposal to streamline the dosing schedule for COVID-19 vaccines by turning them into annual shots
Top FDA Official Involved in Baby Formula Debacle Resigns
Frank Yiannas' role included developing policies on food safety and responding to outbreaks, but the infant formula shortage posed the greatest challenge
FDA Approves New Two-Drug Combo Medicine for Asthma
Medication is the first approved in the United States to contain an inhaled corticosteroid as a reliever rather than as a controller of asthma symptoms
Congressional Report Slams FDA, Drugmaker Over Approval of Alzheimer Drug Aduhelm
Controversy over Aduhelm stretches back to its June 2021 approval by the U.S. Food and Drug Administration
FDA Approves Sunlenca for Treatment-Resistant HIV
Sunlenca is the first capsid inhibitor approved for HIV
FDA Tobacco Unit Overloaded and Lacking Direction, Panel Says
Experts recommend agency leaders set clear objectives and expectations to prevent more 'detrimental’ effects on the agency's work and staff morale
FDA Food Safety Program Needs a Revamp: Panel
Program needs an overhaul with greater attention paid to strong leadership and a more proactive culture
