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May 17, 2020

SCA Pharmaceuticals Issues Voluntary Nationwide Recall of Specific Products Due to Potential Contamination

Summary Company Announcement Date: October 20, 2017 FDA Publish Date: October 20, 2017 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of Sterility Assurance […]
May 15, 2020

Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures

Summary Company Announcement Date: October 05, 2017 FDA Publish Date: October 05, 2017 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Product exposed to […]
May 15, 2020

Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

Summary Company Announcement Date: August 17, 2017 FDA Publish Date: February 09, 2018 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Lack of Sterility […]
May 15, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 15, 2020

For Immediate Release: May 15, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 15, 2020

Impact Story: CDER Assessment of Drug Impurity Mutagenicity by Quantitative Structure-Activity Relationship Modeling

Back to Regulatory Science In Action Before new drug candidates are approved for use in humans, they must undergo a comprehensive panel of non-clinical safety tests. […]
May 15, 2020

FDA approves ripretinib for advanced gastrointestinal stromal tumor

On May 15, 2020, the Food and Drug Administration approved ripretinib (QINLOCK, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have […]
May 15, 2020

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

On May 15, 2020, the Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or […]
May 15, 2020

FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors

For Immediate Release: May 15, 2020 Today, the U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a […]
May 15, 2020

Q1E Evaluation of Stability Data

Docket Number: FDA-2002-D-0180 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations on how […]
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