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FDAAA requirements update: drug safety, clinical trials database

A Draft Guidance for Industry about Medication Guides and REMS has been published for comment purposes (February 2011); the draft Guidance indicates that it is intended to address 2 topics pertaining to Medication Guides for drug and biological products-that is , (i) when the FDA intends to exercise enforcement discretion regarding when a Medication guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient instead of being dispensed directly to the patient for self -administration or to the patient's caregiver for administration to the patient and(ii) when a Medication Guide will be required as part of a risk evaluation and mitigation strategy. FDAAA authorizes the FDA to require a risk evaluation and mitigations strategy (REMS) when necessary to ensure that the benefits of a drug outweigh the risks. Between 3/25/2008 , when the REMS provisions of FDAAA took effect and 1/1/2011 FDA has approved over 150 Medication Guides for products approved under new drug applications (NDAs) and biologic license applications (BLAs) as part of a REMS. (1)
Also of note, as required by FDAAA, FDA states that it is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug, including biological products and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to is the clinical trial registry databank maintained by NIH/NLM which was created by statute. The rule is effective March 7, 2011, the compliance date is March 7, 2012. (2)
Generally, see also the extensive FDAAA Implementation Chart, last updated 3/29/2011.
(1)http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm(2)edocket.access.gpo.gov/2011/pdf/2010-‚Äč33193.pdf

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This page contains a single entry from the blog posted on April 6, 2011 3:05 PM.

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