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Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.

Wang B, Kesselheim AS - BMJ (2015)

Bottom Line: Systematic review.Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014.The cohort included 295 supplemental indications.

View Article: PubMed Central - PubMed

Affiliation: Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, 1620 Tremont St, Boston, MA 02120, USA.

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Fig 1 Construction of study sample
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fig1: Fig 1 Construction of study sample

Mentions: The FDA lists all supplemental new drug applications and supplemental biologic licensing applications on its Drugs@FDA database.7 One author (BW) manually extracted all supplemental application approvals that occurred between 2005 and 2014 from this database, excluding supplements categorized by the FDA as relating to “labeling revisions” and “manufacturing change or addition,” which focus mainly on administrative or logistical modifications and range from minor wording changes in the label to addition of new dosage strengths and adverse events (see table 1 for definitions of key terminology used in the analysis). We then examined the FDA’s letters accompanying the remaining supplemental application approvals to exclude those unrelated to supplemental indications, such as inclusion in the drug label of additional clinical data supporting an already approved indication (fig 1).


Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.

Wang B, Kesselheim AS - BMJ (2015)

Fig 1 Construction of study sample
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4580725&req=5

fig1: Fig 1 Construction of study sample
Mentions: The FDA lists all supplemental new drug applications and supplemental biologic licensing applications on its Drugs@FDA database.7 One author (BW) manually extracted all supplemental application approvals that occurred between 2005 and 2014 from this database, excluding supplements categorized by the FDA as relating to “labeling revisions” and “manufacturing change or addition,” which focus mainly on administrative or logistical modifications and range from minor wording changes in the label to addition of new dosage strengths and adverse events (see table 1 for definitions of key terminology used in the analysis). We then examined the FDA’s letters accompanying the remaining supplemental application approvals to exclude those unrelated to supplemental indications, such as inclusion in the drug label of additional clinical data supporting an already approved indication (fig 1).

Bottom Line: Systematic review.Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014.The cohort included 295 supplemental indications.

View Article: PubMed Central - PubMed

Affiliation: Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, 1620 Tremont St, Boston, MA 02120, USA.

Show MeSH