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April 28, 2020

Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies

Docket Number: FDA-1998-D-0035 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is one of three […]
April 28, 2020

Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications

Docket Number: FDA-1998-D-0035 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is one of three […]
April 28, 2020

Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments

Docket Number: FDA-1998-D-0035 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is one of three […]
April 28, 2020

Drug Trials Snapshot: TUKYSA

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 […]
April 27, 2020

Coronavirus (COVID-19) Update: Daily Roundup April 27, 2020

For Immediate Release: April 27, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
April 27, 2020

Enhanced Accountability & Reporting

In order to promote accountability and transparency, GDUFA II includes provisions so that industry and public stakeholders are able to observe the Agency’s productivity and performance […]
April 27, 2020

Fresenius Kabi’s Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

Summary Company Announcement Date: April 23, 2020 FDA Publish Date: April 27, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description presence of particulate matter […]
April 27, 2020

Assessment of Pressor Effects of Drugs Guidance for Industry

Docket Number: FDA-2018-D-1636 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to advise sponsors on the premarketing […]
April 27, 2020

Assessment of Abuse Potential of Drugs

Docket Number: FDA-2010-D-0026 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors of investigational new drugs and […]
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