Search Results for Tablet

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FDA Accepts for Review First NDA for a 'Digital' Medicine By Zachary Brennan - Published 10 September 2015

The US Food and Drug Administration (FDA) has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet.

Categories: News, US, FDA, Combination products, Drugs, Medical Devices, Submission and registration

Tags: digital medicine, tablet sensor, Abilify, medication adherence

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Tags: Size, Tablet, draft guidance, guidance

FDA Guidance Provides Framework for Testing and Labeling Scored Drug Tablets By Alexander Gaffney, RF News Editor - Published 13 March 2013

Categories: FDA, Labeling

Tags: Scoring, Tablet, pharmaceutical, label, guidance, drug

FDA Plans to Focus on Tablet Scoring, Nanotechnology at Upcoming Meeting By Alexander Gaffney - Published 13 July 2012

Tags: Tablets, Tablet Scoring, nanotechnology, Meeting, Latest News, USP, draft guidance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