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June 17, 2020

Lupus Therapies Continue to Evolve

Sources: U.S. Food and Drug Administration (FDA) and American College of Rheumatology Español It can be a difficult disease to diagnose and a difficult disease to […]
June 17, 2020

Public Meeting: Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI – 08/11/2020 – 08/11/2020

On This Page Date: August 11, 2020 Time: 9:30 AM – 12:30 PM ET The Food and Drug Administration is hosting a public meeting entitled “Independent […]
June 17, 2020

PDUFA VI: Assessment of FDA-Sponsor Communication Practices During the IND Stage of Drug/Biologic Development

During the years of clinical studies required to determine whether a new drug or biologic is safe and effective for human use, FDA staff and product […]
June 17, 2020

Option Care Enterprises, Inc. – 523000 – 04/23/2020

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Douglas L. Dumler Recipient Title General Manager Option Care Enterprises, Inc. 9140 Guilford RoadSuite KColumbia, […]
June 17, 2020

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

On June 16, 2020, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of adult and pediatric […]
June 17, 2020

Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA plays a critical role in protecting the United States from threats […]
June 16, 2020

Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

Docket Number: FDA-2018-D-1893 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research [Final posted 6/16/2020] This guidance (Guidance 1) is the first of a […]
June 16, 2020

Kefauver-Harris Amendments Revolutionized Drug Development

Image President John F. Kennedy hands Sen. Estes Kefauver the pen he used to sign the 1962 Amendments to the Federal Food, Drug and Cosmetic (FD&C) […]
June 16, 2020

FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making

FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit […]
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