Compliance Resources to Help you Stay Current

In January the European Parliament's committee responsible for public health voted in favour of a revised version of the EU Clinical Trial Regulation initially proposed by the European Commission in July 2012.

No. The FDA is trying to increase the representation of women in clinical studies of medical devices. According to the FDA’s recently issued draft guidance on Evaluation of Sex Differences in Medical Device Clinical Studies, medical device clinical trial sponsors can create tailored communication strategies (as used in the Women’s Health Initiative study) for study recruitment, informed consent documents and patient labeling.

The guidance also recommends that device manufacturers and developers, where appropriate, can target investigational sites where recruitment of women can be more easily facilitated. These investigational sites include women’s clinics.

Read an overview and summary of recommendations of the new FDA draft guidance aimed at increasing the representation of women in device clinical studies.
 

The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials.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.

This article gives an overview and summary of recommendations included in this FDA draft guidance.
 

No. The FDA's Abbreviated New Drug Application or ANDA process, used by generic manufacturers to apply for approval for their copies of drugs, does not require the company to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.

Instead, generic manufacturers need to show that their product is bioequivalent or performs in the same manner as the original, innovator drug.

Bioequivalence can be demonstrated by measuring the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.

The FDA released draft guidance in May 2011 to assist clinical investigators, industry and FDA staff in interpreting and complying with regulations governing financial disclosures by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

This article gives an overview of the recommendations included in the draft guidance. Comments on these draft guidelines were due by July 25, 2011.

The Centers for Medicare & Medicaid Services regulate all laboratory-testing performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). CLIA covers approximately 200,000 laboratories. The Division of Laboratory Services, within the Survey and Certification Group of the Center for Medicaid and State Operations, implements the CLIA.

This article will discuss the increasing trend of protocol enrollment violations, how enrollment violations produces detrimental effects on premarket clinical trials, and how sponsors/CROs, sites and CRAs can help minimize future violations in an effort to increase subject safety and data integrity.

This article proposes a discussion about the development of Clinical Trials in Brazil, one particular country that integrates the “emerging market” for the Pharmaceutical Products.

Institutional Review Boards have been constituted to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of research subjects. They are vested with the responsibility of enforcing federal regulations that apply to clinical trials. IRBs are responsible for the following

•     Annual reviews of research (or more regularly based on risk)
•     Determining if independent review of the investigator is required to determine if material changes have occurred since previous review
•     Ensuring that any changes to research plans are communicated to and approved by the IRB
•     Suspending or terminating approval of research that is being conducted outside of IRB requirements
•     Approval of informed consent documents

IRBs are expected to be mindful of their role in protecting human subjects and must carefully screen all documents received by them from sponsors for their efficacy.

Toxicology, Pharmacovigilance, Drug Safety Evaluation - Explained

Toxicology is the study of adverse effects of chemicals on living organisms. It is the study of symptoms, treatments and detection of poisoning. The relationship between the dosage and its effect on the exposed organism is of high importance in toxicology. Investigative toxicology focus on making drugs safe for human use. It involves a series of clinical tests on lab specimens (mostly rats) to access the risk of any toxic reactions before human trials. Drug safety evaluation or more so known as Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of adverse effects of medications, biological products, herbalism and traditional medicines, particularly long term and short term side effects. The aim is to collect new information on hazards of medicines and to prevent harm to patients.

Availability of volunteers for clinical trials has always been a challenge. Uncertainity of the outcome has always been a deterant. More so in recent times researchers have been focussing on treatment for rare diseases. So this reduces the target population to a niche. So much of time is being invested in developing these drugs. But lack of volunteers is delaying the process of mass manufacture. Communicating the efficacy of such trials is also another challenge that these researchers face.