Center For Drug Evaluation And Research (cder) - Biotechnology

Relevant Publications

2023 in review: FDA approvals of new medicines.

Issue Release: 2024

sendigR: an R package to leverage the value of CDISC SEND datasets for cross-study analysis.

Issue Release: 2024

A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks.

Issue Release: 2024

A network of regulatory innovations to improve FDA quality assessments of human drug applications.

Issue Release: 2024

Clinical pharmacology considerations for first-in-human clinical trials for enzyme replacement therapy.

Issue Release: 2024

Understanding the Regulatory Pathways Used to Develop, Evaluate, Authorize, and Approve New Drugs and Vaccines in the United States.

Issue Release: 2024

Blood product use for radiological/nuclear trauma: product development and US regulatory considerations.

Issue Release: 2024

Ensuring safety and efficacy in combination products: regulatory challenges and best practices.

Issue Release: 2024

Lessons from CDER\'s Quality Management Maturity Pilot Programs.

Issue Release: 2023

Pharmacological profile of novel anti-cancer drugs approved by USFDA in 2022: A Review.

Issue Release: 2023

Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions.

Issue Release: 2023

Determination of vitamin D conjugated metabolites: a complementary view on hydroxylated metabolites.

Issue Release: 2023

2022 in review: FDA approvals of new medicines.

Issue Release: 2023

Society for Maternal-Fetal Medicine Special Statement: Response to the Food and Drug Administration\'s withdrawal of 17-alpha hydroxyprogesterone caproate.

Issue Release: 2023

Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017-2019.

Issue Release: 2023

Creating a Roadmap to Quantitative Systems Pharmacology-Informed Rare Disease Drug Development: A Workshop Report.

Issue Release: 2023

FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010-2020.

Issue Release: 2022

Development and validation of a headspace GC-MS method to evaluate the interconversion of impurities and the product quality of liquid hand sanitizers.

Issue Release: 2022

Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER.

Issue Release: 2022

FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations.

Issue Release: 2022

What is Bioaugmentation?

What are Mine Tailings?

What is the Role of Public Perception?

Why is Real-Time Monitoring Important?

What Are the Challenges and Limitations of Remote Sensing in Biotechnology?

What are the Ethical Concerns in Biotechnology?

What are the Applications of Gene Cloning?

What are Stem Cells?

What is Bioterrorism?

What are the Potential Risks and Misuse of Copper in Biotechnology?

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