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May 11, 2020

Plum Dragon Herbs, Inc. – 05/08/2020

Product: Drugs Recipient: Recipient Name Lisa Ball Plum Dragon Herbs, Inc. 102 Chester VillageChester, MD 21619United States [email protected] Issuing Office: Center for Drug Evaluation and Research […]
May 11, 2020

Seanjari Preeti Womb Healing, L.L.C. – 607355 – 05/08/2020

Product: Drugs Recipient: Recipient Name Ivy Ruffin (Sagarius) Seanjari Preeti Womb Healing, L.L.C. 1000 North Pine StreetSpartanburg, SC 29303United States [email protected] Date:          May 8, 2020 […]
May 11, 2020

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

On May 8, 2020, the Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMO, Eli Lilly and Company) for the following indications: Adult patients with […]
May 8, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 8, 2020

For Immediate Release: May 08, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 8, 2020

FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion

For Immediate Release: May 08, 2020 Today, the U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell […]
May 8, 2020

ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer’s Injection, USP Due to the Presence of Particulate Matter

Summary Company Announcement Date: May 08, 2020 FDA Publish Date: May 08, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulates (iron […]
May 8, 2020

Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry

Docket Number: FDA-2016-D-1224 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health […]
May 8, 2020

Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry

Docket Number: FDA-2016-D-1673 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes a process for updating labeling for abbreviated new drug […]
May 8, 2020

CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock

Docket Number: None found Issued by: Guidance Issuing Office Center for Drug Evaluation and Research POLICY: A pharmacist should not return drugs products to his stock […]
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