Search Results for Physician Labeling Rule

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FDA Offers Recommendations on Highlights Section of Labeling By Michael Mezher - Published 18 January 2018

The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Labeling

Tags: Highlights, Prescribing Information, Physician Labeling Rule

FDA Scraps Pregnancy Labeling Classification System in Favor of New Standard By Alexander Gaffney, RAC - Published 03 December 2014

The labeling on many prescription drug products approved after 2001 will need to be reconfigured to include clearer information about whether a drug is safe to use during pregnancy, the US Food and Drug Administration (FDA) announced today.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Labeling

Tags: Pregnant, Pregnancy, Nursing, Fetus, Labeling, PLR, Physician Labeling Rule, Pregnancy and Lactation Labeling Rule, PLLR, Draft Guidance, Guidance, Final Rule

FDA Moves Forward With Drug Labeling Revision Project By Alexander Gaffney, RAC - Published 06 May 2014

Categories: US, FDA, Labeling

Tags: PDLI-EI, Physician Labeling Rule, PLR, Latest News