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November 30, 2020

Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry

Submit Comments by 02/26/2021 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
November 30, 2020

Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program

Drug Development Tools (DDTs) are methods, materials, or measures that have the potential to facilitate drug development. As described in the 21st Century Cures legislation, DDTs […]
November 27, 2020

FDA approves device for treatment of osteoid osteoma in the extremities

On November 27, 2020, the Food and Drug Administration approved the Sonalleve MR-HIFU system (Profound Medical Inc.) for the treatment of osteoid osteoma in the extremities. […]
November 27, 2020

Report Kids’ Problems With Medical Products

Español Consumers can play a critical role in helping the Food and Drug Administration (FDA) assure children’s access to safe medical products. Reporting to FDA such […]
November 27, 2020

Some Medications and Driving Don’t Mix

If you are taking a medication, is it OK to drive? Most likely, yes. But the Food and Drug Administration (FDA) advises that it’s best to […]
November 25, 2020

FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

On November 24, 2020, the Food and Drug Administration granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics, Inc.) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for […]
November 25, 2020

Remdesivir (Veklury) Approval for the Treatment of COVID-19—The Evidence for Safety and Efficacy

Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s).  The approval of […]
November 24, 2020

Coronavirus (COVID-19) Update: November 24, 2020

For Immediate Release: November 24, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
November 24, 2020

Public Notification: Body Shape Weight Loss System contains hidden drug ingredient

[11-24-2020] The Food and Drug Administration is advising consumers not to purchase or use Body Shape Weight Loss System, a product promoted for weight loss. This […]
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