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Multi-Regional Clinical Trials: ICH and FDA General Principles for Planning and Design

  • Industry: Clinical Research

Multi-Regional Clinical Trials: ICH and FDA General Principles for Planning and Design

With the increasing globalization of drug development, the use of multi-regional clinical trials (MRCTs) for regulatory submissions has increased. Regulatory authorities in different countries such as Japan, USA, EU and China have issued the guidance documents on MRCTs. ICH has started the process for having a harmonized guidance document on MRCTs and the document is likely to be issued in 2017.

FDA Issues Final Guidance on the Use of Electronic Informed Consent

  • Industry: Clinical Research

FDA Issues Final Guidance on the Use of Electronic Informed Consent

The informed consent process has been an area of debate over the past few years. Regulations and guidelines controlling the conduct of clinical trials require informed consent to be obtained from each study subject prior to initiation of clinical investigation. In December 2016, FDA published its final guidance on the use of electronic informed consent. This guidance document finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” published in March 2015.

FDA ANDA Submissions Guidance - Prior Approval Supplements under GDUFA

  • Industry: Drugs and Chemicals (Pharma)

FDA ANDA Submissions Guidance – Prior Approval Supplements under GDUFA

US FDA has issued a guidance, in October 2016, to aid pharma companies preparing to submit prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the FD&C Act. The guidance further explains how the GDUFA relates to PAS submissions. Specifically, the guidance focuses on the following key areas:

Assessment of Abuse Potential of Drugs - Guidance for Industry

  • Industry: Drugs and Chemicals (Pharma)

Assessment of Abuse Potential of Drugs - Guidance for Industry

Abuse-Deterrent Opioids (Evaluation and Labeling) - Guidance for Industry

With the intent to assist applicants who seek approval for a new drug, particularly to evaluate the abuse potential of the drug, and to assist sponsors of investigational new drugs, these FDA guidance seek to offer insight into key decision points such as recommended studies in assessing abuse potential, cases when abuse-related studies should be conducted, preparing the NDA submission, NDA review and product labeling related to abuse potential, and the drug scheduling process.

FDA Guidance on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

  • Industry: Clinical Research

FDA Guidance on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

The conduct of clinical trials are monitored through variety of approaches that differ between businesses, government organization, and educational institutions. Considering this variability, the FDA guidance describes the risk based strategy for monitoring, including the use of on-site monitoring, centralized monitoring, and additional alternative monitoring techniques

FDA Guidance on Clinical Investigator Roles and Responsibilities

  • Industry: Clinical Research

FDA Guidance on Clinical Investigator Roles and Responsibilities

Investigators conducting the clinical trials should meet all research expectations including FDA requirements and Good Clinical Practice (GCP) guidelines. Investigators must be diligent throughout the conduct of the trial from designing the protocol, determining which trials to perform, during the conduct and after completion of the study.

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance

  • Industry: Clinical Research

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Guidance

Pharmacovigilance plays a pivotal role in safeguarding ongoing safety of drug products. It is impossible to recognize all safety concerns during clinical trials. Once a drug is marketed, it is usually exposed to a large number of patients including those with co-morbid conditions.

Post marketing safety drug monitoring includes finding of drug interactions, evaluating the influence of inactive ingredients to the safety profile, methods for comparing safety profiles of similar drugs, investigation of the adverse effects on human health of drug residues in animals, e.g. antibiotics and hormones.

FDA Draft Guidance on Evaluation of Sex Differences in Medical Device Clinical Studies

  • Industry: Medical Devices

The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials. Aimed at medical device manufacturers and developers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

FDA Guidance on Adverse Event Reporting to IRBs - Improving Human Subject Protection

  • Industry: Clinical Research

The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects. Institutional Review Board (IRB) reviews and approves the clinical protocol, informed consent forms, study advertisements, and patient brochures.

FDA 2011 Draft Guidance on Financial Disclosure by Clinical Investigators

  • Industry: Clinical Research

The FDA released draft guidance in May 2011 to assist clinical investigators, industry and FDA staff in interpreting and complying with regulations governing financial disclosures by clinical investigators, 21 CFR Part 54.

Improving Access to Clinical Trials Act of 2009

  • Industry: Clinical Research

Improving Access to Clinical Trials Act of 2010 amends title XVI (Supplemental Security Income) (SSI) of the Social Security Act (SSA) to exclude from income for SSI eligibility purposes any compensation in the amount of the first $2,000 per year received by an individual for participation in clinical trials involving research and testing of treatments for rare diseases or conditions.

The Act amends SSA title XIX (Medicaid) to make a similar exclusion from income of such compensation for the purposes of eligibility under the Medicaid program.
The Act directs the Comptroller General to study and report to Congress on the impact of this Act on enrollment of individuals who receive SSI benefits in clinical trials for rare diseases or conditions.

Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Adverse Event ....

  • Industry: Clinical Research

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach ifthe approach satisfies the requirements ofthe applicable statutes and regulations. If you want to discuss an alternative approach, contact
the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriatetelephone number listed on the title page ofthis guidance.

Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

  • Industry: Clinical Research

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance

 

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Card ....

  • Industry: Clinical Research

The Food and Drug Administration (FDA) is announcing the classification of cardiac allograft gene expression profiling test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ‘‘Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems.’’ FDA classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device

Effective Date:This rule is effective November 20, 2009

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