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January 22, 2021

FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma

On January 22, 2021, the Food and Drug Administration approved  the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for […]
January 22, 2021

Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA

These tables provide the current number of Drug Development Tool (DDT) projects grouped overall, by Program, and DDT stage. Please note, the stage of the DDT […]
January 22, 2021

Getting it Right: Retention Samples for BA and BE Studies – 03/19/2021 – 03/19/2021

On This Page Date: March 19, 2021 Time: 1:00 PM – 2:00 PM ET This webinar is FREE. This webinar is intended to help applicants submitting […]
January 21, 2021

Types of Drug Master Files (DMFs)

Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product The Generic Drug User Fee Amendments (GDUFA) include provisions for […]
January 21, 2021

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

For Immediate Release: January 21, 2021 The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the […]
January 21, 2021

Orange Book Preface

Food and Drug AdministrationCenter for Drug Evaluation and ResearchApproved Drug Products with Therapeutic Equivalence Evaluations The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, […]
January 21, 2021

FDA Safety Report Type Flag Requirement for FAERS Submissions – 02/19/2021 – 02/19/2021

On This Page Date: February 19, 2021 Time: 1:00 PM – 2:00 PM ET   This webinar is FREE. FDA will introduce the FAERS FDA Safety […]
January 21, 2021

DDT COA #000006: Asthma Daily Symptom Diary (ADSD)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Pulmonary, Allergy, and Critical Care (DPACC) DDT COA NumberDDT COA #000006 Instrument NameAsthma Daytime Symptom Diary […]
January 21, 2021

Novel Drug Approvals for 2021

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) […]
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