|Year : 2010 | Volume
| Issue : 2 | Page : 80-81
|Date of Web Publication||20-Oct-2010|
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
. Regulatory News. Perspect Clin Res 2010;1:80-1
| FDA Guidance Documents|| |
Adaptive Design Clinical Trials for Drugs and Biologics
- This guidance provides sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with information regarding adaptive design clinical trials when used in drug development programs. This guidance gives advice on topics such as (1) what aspects of adaptive design trials (i.e., clinical, statistical, regulatory) call for special consideration, (2) when to interact with FDA while planning and conducting adaptive design studies, (3) what information to include in the adaptive design for FDA review, and (4) issues to consider in the evaluation of a completed adaptive design study. This guidance is intended to assist sponsors in planning and conducting adaptive design clinical studies, and to facilitate an efficient FDA 26 review.
Non-Inferiority Clinical Trials
- This guidance provides sponsors and review staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER) at the Food and 18 Drug Administration (FDA) with our interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic.2 The guidance gives advice on when NI studies can be interpretable, on how to choose the NI margin, and how to analyze the results.
Guidance for Institutional Review Boards (IRBs) Frequently Asked Questions - IRB Registration
- This guidance is intended to assist institutional review boards (IRBs) in complying with the new requirement for IRB registration. (See 74 FR 2358 (Jan. 15, 2009))1 This requirement is an amendment to Part 56, Institutional Review Boards, (21 CFR 56.106), that requires each IRB in the United States (U.S.) that reviews FDA-regulated studies to register
Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects
- This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). The goal of this guidance is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. This guidance is intended to clarify for investigators and sponsors FDA's expectations concerning the investigator's responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights, safety, and welfare of study subjects.
| European Medicines Agency Guidelines|| |
The Investigation of Bioequivalence
- This guideline focuses on recommendations for bioequivalence studies for immediate release formulations with systemic action. It also sets the relevant criteria under which bioavailability studies need not be required
Clinical Investigation Of Medicinal Products Used In The Treatment Of Osteoarthritis
- The scope of this guideline is to provide a European common position on pertinent issues relating to the clinical evaluation of medicinal products for the treatment of osteoarthritis
Guideline On Clinical Investigation Of Medicinal Products In The Treatment Of Epileptic Disorders
- The scope of this document is restricted to treatment of seizures in epileptic disorder although there are some remarks concerning non-seizure features of epilepsy syndromes. The guideline is intended to assist applicants in the interpretation with respect to specific problems presented by products in epileptic disorders.
Guideline On The Evaluation Of Drugs For The Treatment Of Gastroesophageal Reflux Disease
- This guideline is intended to assist applicants during the development of products for the treatment of GERD in adults and children, where no current regulatory guidance exists in the EU.
| Cdsco|| |
Documents to be submitted for grant of permission to conduct Bioequivalence studies for export purpose.
The scope of this guidance covers
- Requirements for BE study of a new molecule not approved in India but approved in the other countries.
- New Drugs approved in India within period of 1 year New Drugs approved within period of more than 1 year and less than 4 years
- BE NOC for all the drug products in modified release form irrespective of their approval status