What is FDA risk based monitoring?
A risk-based approach to monitoring does not suggest any less vigilance in oversight of clinical investigations. Rather, it focuses sponsor oversight activities on preventing or mitigating important and likely risks to data quality and to processes critical to human subject protection and trial integrity.
What is the pediatric Research Equity Act?
The Pediatric Research Equity Act amends the federal Food, Drug, and Cosmetic Act to authorize the FDA to require pediatric studies of drugs or biologics when other approaches are insufficient to ensure that the products are safe and effective for use in children.
What is FDA pediatric exclusivity?
L. 105-115), Congress enacted a new law that provides marketing incentives to manufacturers who conduct studies of drugs in children. This law, which provides six months exclusivity in return for conducting pediatric studies, is commonly known as the pediatric exclusivity provision.
What are the sponsor’s responsibilities in a trial that is federally funded and regulated by the FDA?
The sponsor is responsible for monitoring and analyzing these investigator reports and relaying them as required to FDA, other regulatory authorities (as appropriate) and other investigators (21 CFR 312.32(c), 21 CFR 812.40).
What triggers PREA?
PREA: Is triggered by an application for a new indication, new dosage form, a new dosing regimen, a new route of administration or a new active ingredient. Authorizes FDA to require a pediatric assessment of some approved drug/biologic products for certain indications.
How are biologics regulated FDA?
Biological products are a subset of drugs; therefore both are regulated under provisions of the FDC Act. However, only biological products are licensed under section 351 of the PHS Act. FDA approval to market a biologic is granted by issuance of a biologics license.
Which legislation addresses product development in children?
the pediatric legislation: BPCA and PREA. adults with additional ethical protections for children (Subpart D 21CFR 50.50-50.56).
How do you perform risk based monitoring?
Guidance from the US Food and Drug Administration (FDA) outlines three steps in a risk-based approach to monitoring:
- Identify critical data and processes.
- Perform a risk assessment.
- Develop a monitoring plan.
Does the FDA monitor clinical trials?
FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. …
Why are children at a higher risk than adults for medication administration errors?
Because the increase in metabolic rate in children is often greater than that in adults, children may require higher doses on a milligram-per-kilogram basis or more frequent dosing compared to adults.
How does pediatric exclusivity work?
Pediatric exclusivity does not accrue only to the product that was studied in the pediatric population. It attaches to all the applicant’s formulations, dosage forms, and indications for products with existing marketing exclusivity or patent life that contain the same active moiety.