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March 19, 2021

Coronavirus (COVID-19) Update: March 19, 2021

For Immediate Release: March 19, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
March 19, 2021

FDA D.I.S.C.O. Burst Edition: Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved test

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
March 18, 2021

FDA Approves First Treatment for Disease That Causes Recurrent Inflammation in Sac Surrounding Heart

FDA has approved Arcalyst (rilonacept) injection to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 years and older.   Recurrent pericarditis […]
March 18, 2021

Withdrawn CDER Product Specific Guidances

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
March 18, 2021

Drug Safety-related Labeling Changes (SrLC) Database Overview: Updates to Safety Information in FDA-Approved Prescription Drug Labeling

The Drug Safety-related Labeling Changes (SrLC) database includes updates to safety information in labeling for human prescription drugs regulated under NDAs and human prescription biological products […]
March 18, 2021

FDA authorizes revisions to fact sheets to address SARS-CoV-2 variants for monoclonal antibody products under emergency use authorization

Today, the U.S. Food and Drug Administration authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each […]
March 18, 2021

FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic

Image By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs and Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs Over the past year, the […]
March 18, 2021

Drug Trials Snapshots: ZULRESSO

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
March 18, 2021

Drug Trials Snapshot: CABLIVI

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
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