Tag: FDA guidance

FDA guidance

Regulatory/FDA

FDA Plans Expedited Approval Path for Modified COVID-19 Vaccines

FDA Plans Expedited Approval Path for Modified COVID-19 Vaccines

Feb. 8, 2021 – With growing concern about the spread of new COVID-19 variants, companies developing vaccine modifications will not have to “start at square one,” according to Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, M.D.. Because of early indications that the initial vaccines may have lower effectiveness against one or more of […]

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Regulatory/FDA

New FDA Guidance on Clinical Trial Design—and an Admonition from Commissioner Gottlieb

New FDA Guidance on Clinical Trial Design—and an Admonition from Commissioner Gottlieb

March 18, 2019 — With mere days left before his departure as FDA Commissioner, Dr. Scott Gottlieb is trying to focus attention on one of the lesser-known of his major initiatives – improving the design of clinical trials in drug development. In a statement released along with the publication of a new guidance, Gottlieb highlighted […]

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Regulatory/FDA

FDA Finalizes Guidance on Name Placement, Size and Prominence

FDA Finalizes Guidance on Name Placement, Size and Prominence

Dec. 15, 2017 – The FDA announced this week that it has finalized its guidance document covering how industry should treat product name placement, size and prominence in promotional labeling and ads, largely keeping intact the draft guidance document it issued on the matter in 2013, and reiterating the agency’s position that “the disclosure of […]

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Regulatory/FDA

OPDP Plans Just One Guidance Document for 2017

OPDP Plans Just One Guidance Document for 2017

Feb. 20, 2017 – Although the FDA announced last August that it would issue four advertising-related guidance documents by the end of 2016, the Office of Prescription Drug Promotion (OPDP) fell short of that goal and apparently will set a very low bar for 2017: It plans to issue only one guidance document in 2017. […]

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Industry More Than Ready for FDA Off-label Communications Guidance

Feb. 2, 2016 – The FDA’s recent announcement regarding which new and revised guidance documents it plans to publish in 2016 includes four long-awaited guidance documents by the Office of Prescription Drug Promotion (OPDP). “While the agency has been pondering its options, consumers and health professionals are expecting the industry to move forward and participate […]

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FDA Issues Updated Draft Guidance on Distributing Scientific and Medical Info on Unapproved New Uses

March 3, 2014 – The FDA announced today the availability of a new draft guidance (2014-04560) on distributing scientific and medical publications on unapproved uses that updates a 2009 draft guidance on the topic, provides recommended practices for the dissemination of scientific or medical journal articles and scientific or medical reference texts and, importantly, adds […]

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Coalition Seeks Input on FDA Online Promotion Guidance

Jan. 23, 2014 – The Coalition for Healthcare Communication would like to receive feedback from its members regarding the FDA social media draft guidance released Jan. 13: “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.” (See related article at http://www.cohealthcom.org/?p=2439.)The Coalition is creating a subcommittee […]

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