Search Results for Size

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Generic Drugs Should Look Similar to the Drugs They Reference, FDA Says By Alexander Gaffney, RAC - Published 18 June 2015

The US Food and Drug Administration (FDA) is recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference.

Categories: News, US, CDER, Generic drugs, Prescription drugs, Submission and registration

Tags: Guidance, Final Guidance, RLD, Tablest, Capsules, Size, Shape, Color, Taste

FDA to Study Effect of Generic Drug Appearance on Patient Adherence By Alexander Gaffney, RAC - Published 14 May 2015

Does the color, shape or size of a generic drug affect how willing patients are to adhere to existing treatment regimens? The US Food and Drug Administration (FDA) wants to know.

Categories: News, US, CDER, Generic drugs

Tags: Physical Characteristics, Size, Color, Shape, Study

FDA Wants to Study if Drug Color, Shape and Size Affect Patient Adherence By Alexander Gaffney, RAC - Published 15 October 2014

US drug regulators have long known that the physical attributes of a drug product can affect its safety and efficacy. Now the US Food and Drug Administration (FDA) wants to know exactly how a change in a drug's appearance affects patient adherence.

Categories: News, US, CDER, Generic drugs, Prescription drugs

Tags: Pill, Shape, Tablet, Color, Size, Survey, Patient Adherence

FDA to Generic Sponsors: Physical Attributes Should be Similar, if not the Same By Alexander Gaffney, RF News Editor - Published 09 December 2013

Categories: US, FDA

Tags: Size, Tablet, draft guidance, guidance

Study: Many Clinical Trials Small, of Poor Quality By Alexander Gaffney - Published 02 May 2012

Categories: Quality

Tags: ClinicalTrials.gov, JAMA, Size, analysis, Latest News, study, clinical trials

FDA Provides New Guidance for Promotional Labeling and Advertising By Alexander Gaffney - Published 25 January 2012

Categories: FDA, Labeling

Tags: Prominence, Placement, Size, APL, Guidance for Industry, Latest News, promotional, advertising, guidance

FDA: Tablet Size Matters for Generics By Alexander Gaffney - Published 06 January 2012

Categories: FDA

Tags: Size, Generic, RLD, OGD, ANDA, Tablet, Latest News