Fdaaa Medical

Food and Drug Administration Amendments Act …

https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-amendments-act-fdaaa-2007

Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized …

FDAAA 801 and the Final Rule - ClinicalTrials.gov

https://clinicaltrials.gov/ct2/manage-recs/fdaaa

FDAAA 801 and the Final Rule. This page summarizes the clinical trial registration and results information submission requirements described in Section 801 of the Food and …

FDA's Role: ClinicalTrials.gov Information | FDA

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fdas-role-clinicaltrialsgov-information

What is FDA’s Role Related to ClinicalTrials.gov? The Food and Drug Administration Amendments Act of 2007 ( FDAAA) requires that the “Responsible Party” …

FDA's Sentinel Initiative | FDA

https://www.fda.gov/safety/fdas-sentinel-initiative

Monitoring the safety of its regulated products is a major part of the FDA’s mission to protect public health. Sentinel is the FDA’s national electronic system which …

Food and Drug Administration Amendments Act of 2007

https://en.wikipedia.org/wiki/Food_and_Drug_Administration_Amendments_Act_of_2007

FDAAA Implementation – Highlights One Year After …

https://www.fda.gov/regulatory-information/food-and-drug-administration-amendments-act-fdaaa-2007/fdaaa-implementation-highlights-one-year-after-enactment

FDAAA provides FDA with additional requirements, authorities, and resources with regard to both pre- and postmarket drug safety. The statute contains important new authorities to …

Identifying an “Applicable Clinical Trial” under FDAAA

https://grants.nih.gov/ClinicalTrials_fdaaa/docs/Flow_chart-ACT_only.pdf

drug clinical trial, it may be subject to pre-existing registration requirements under the Food and Drug Administration Modernization Act (FDAMA) of 1997. ... then the ACT is not …

Regulatory ClinicalTrials.gov and FDAAA Frequently …

https://rsc.niaid.nih.gov/about-us/regulatory-clinicaltrialsgov-and-fdaaa-faqs

FDAAA requires registration and basic results posting of applicable clinical trials. If your study does not fall under the requirements for an applicable clinical trial, it …

FDAAA Implementation Chart | FDA

https://www.fda.gov/regulatory-information/food-and-drug-administration-amendments-act-fdaaa-2007/fdaaa-implementation-chart

FDAAA Implementation Chart | FDA FDAAA Implementation Chart For additional information about the implementation of the Prescription Drug User Fee Act (PDUFA) IV …

Advertising & Promotional Labeling Questions and Answers

https://www.fda.gov/vaccines-blood-biologics/labeling-cber-regulated-products/advertising-promotional-labeling-questions-and-answers

Section 906 of FDAAA went into effect on March 25, 2008 and amended Section 502 (n) of the Federal Food, Drug, and Cosmetic Act (FDCA), which now mandates that published …