What does DB VI (CDER) mean in FDA
The Division of Biometrics VI (CDER) is a branch of the United States Food and Drug Administration (FDA). The FDA is an agency within the Department of Health and Human Services that is responsible for regulating medical products, foods, drugs, cosmetics, and more. CDER is responsible for evaluating new drug applications and employing scientific techniques to ensure safety and effectiveness of drug products. DB VI (CDER) stands for Division of Biometrics VI in the Center for Drug Evaluation and Research.
DB VI (CDER) meaning in FDA in Governmental
DB VI (CDER) mostly used in an acronym FDA in Category Governmental that means Division of Biometrics VI (CDER)
Shorthand: DB VI (CDER),
Full Form: Division of Biometrics VI (CDER)
For more information of "Division of Biometrics VI (CDER)", see the section below.
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What Does DB VI (CDER) Stand For?
DB VI (CDER) stands for Division of Biometrics VI in the Center for Drug Evaluation and Research. This division is responsible for developing innovative methods to evaluate drugs in terms of safety, quality, efficacy, dosage form, therapeutic indication, labelling, evaluation procedure and other clinical aspects. The Division works closely with other parts of FDA to ensure that all proposed regulations are based on sound scientific evidence.
Essential Questions and Answers on Division of Biometrics VI (CDER) in "GOVERNMENTAL»FDA"
What is Division of Biometrics VI (CDER)?
The Division of Biometrics VI (CDER) is a branch within the US Food and Drug Administration (FDA). This division focuses on supporting FDA’s mission in protecting and promoting human health by providing expertise in the use of biostatistical methods for the evaluation of safety and effectiveness of medical products.
What areas does the Division of Biometrics VI (CDER) focus on?
The Division concentrates on supporting FDA’s mission in protecting and promoting human health by providing expertise regarding the application and evaluation of biostatistics in regulatory decision making. They specialize in areas such as clinical trial design, sample size calculations, data analysis plans, data mining, Bayesian methods, pharmacokinetics/pharmacodynamics (PK/PD), patient-reported outcomes, biosimilars, boarder line approval decisions, risk assessment methodologies and other emerging statistical topics.
What types of services does the Division of Biometrics VI (CDER) provide?
The Division provides many types of services including consultation to FDA staff regarding project development for research initiatives, study designs for clinical investigations or other scientific studies related to medical products. The team also provides training programs that help build competencies across all aspects of medical product development as well as computational analyses related to regulatory submissions and reviews.
How can I contact the Division of Biometrics VI (CDER)?
You can contact this division by sending an email to [email protected] or by calling 301-796-6331.
Is there any online resources available from the Division?
Yes! There are a variety online resources available from this Division such as a website specifically dedicated to answering questions about FDAs Guidelines for Submitting Statistical Information with Applications and Submissions under 21 CFR Part 11. It also provides information about bioequivalence requirements and statistical considerations associated with Abbreviated New Drug Applications (ANDA). Additionally, Guidance documents are also available focusing on general statistical principles used in medical product development and evaluations.
Is there special guidance provided by the Division for drug approvals?
Yes! The team provides guidance pertaining to drug approvals through their publication “Statistical Principles for Clinical Trials” which offers practical advice on appropriate study designs for various types clinical trials depending upon objectives set forth by applicants or sponsors seeking approval from FDA.
Does this Division provide input into new regulations related to biostatistics?
Yes! This division contributes significantly towards developing regulatory framework pertaining to statistical principles used in medical product development or review process conducted by FDA such as implementing risk assessment methodologies or issuing draft guidance documents requiring industry specific standards when conducting clinical trials or submitting applications that involve biological products or medical device regulation activities outlined under 21 CFR Parts 50-99 & 210-211.
Where can I find more information regarding risk assessment methodologies developed by this division?
You can find more information about Risk Assessment Methodologies developed by this division through their publication “Risk Assessment Godfather” which provides statistical methods applied to evaluate safety risks associated with certain type products during preclinical stages or postmarket surveillance programs implemented afterwards depending upon unique circumstances presented appointed case basis.
Final Words:
In conclusion, DB VI (CDER) stands for Division of Biometrics VI in the Center for Drug Evaluation and Research. This division plays a vital role in ensuring medications are safe and effective when they reach patients by developing advanced methodologies to assess the drug's quality, safety levels, efficacy data as well as its dosage form or therapeutic indication. This helps provide healthcare professionals with accurate information needed to help them make informed decisions with regards to prescribing medications to their patients.