Search Results for Communication

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FDA Draft Guidance for Medical Product Communications By Alan Bergstrom - Published 13 September 2017

This article focuses on the US Food and Drug Administration's (FDA's) draft guidance as it impacts prescription drug promotion and offers examples regarding information considered consistent with labeling. It emphasizes the need for regulatory professionals to better understand and adhere to FDA's evidentiary standards by utilizing examples of the Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Marketing and Communications, enforcement actions that should be considered when interpreting what is "consistent with labeling."

Categories: Features, FDA, Communication, Labeling

Tags: Communication, Labeling

FDA Warns of Serious Risks for Syringe Pumps at Low Infusion Rates By Michael Mezher - Published 25 August 2016

The US Food and Drug Administration (FDA) on Thursday issued a warning to healthcare providers over serious adverse events tied to programmable syringe pumps when set to deliver drugs at lower volumes, especially for infants and critically ill patients.

Categories: News, US, FDA, Labeling, Medical Devices, Postmarket surveillance

Tags: Syringe pumps, Safety communication

RAPS and the Regulatory Profession: Two-Way Communication Between Industry and Regulators By Mary Meahger - Published 22 August 2016

When the regulatory profession convenes for the 2016 Regulatory Convergence in San Jose next month, it will be an occasion for members from both government and industry to build on their working relationships, to discuss with one another new guidelines and compliance issues and, generally, to bridge their understanding about regulatory matters unique to those who work in different facets of the profession.

Categories: HTML, Articles, Under RAPS, About the Profession, Communication

Tags: RAPS 40th Anniversary, regulatory profession, communication

Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds By Michael Mezher - Published 15 February 2016

Two safety communications issued by the US Food and Drug Administration (FDA) had different impacts on the use of surgical mesh to treat pelvic organ prolapse (POP), according to a recent study appearing in JAMA Internal Medicine.

Categories: News, US, FDA, Communication, Medical Devices, Postmarket surveillance

Tags: Surgical mesh, Transvaginal mesh, Pelvic organ prolapse, Safety communication

The Biggest Challenge for Regulators That No One's Talking About: Translation By Michael Mezher - Published 04 May 2015

Regulators have long been concerned with the safety, efficacy and quality of the products they regulate. Now they have a new concern to think about: language.

Categories: News, Korea, MFDS, Communication, Government affairs

Tags: Language barriers, communication

European Industry Group Calls for Drug Shortage Reporting Standards By Michael Mezher - Published 02 February 2015

A group of four pharmaceutical industry associations in Europe is proposing a set of guidelines meant to help European National Competent Authorities (NCAs) and the European Medicines Agency (EMA) alleviate drug shortages through better communication.

Categories: News, Europe, EMA, Communication, Crisis management, Manufacturing, Product withdrawl and retirement

Tags: EFPIA, drug shortages, communication, GMP

FDA Wants Input on How to Improve Clinical Trials Process for Industry By Alexander Gaffney, RAC - Published 28 October 2014

The US Food and Drug Administration (FDA) wants the public's feedback on ways it can make it easier to communicate with the agency during the clinical trials process.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Communication, Drugs

Tags: IND, Communication, Guidance, PDUFA

Researchers Say FDA Should Take More Active Role in Disseminating Drug Safety Warnings By Alexander Gaffney, RAC - Published 27 June 2014

In addition to approving products and making sure bad ones never make it to market, an indispensable role of healthcare product regulators is warning consumers and healthcare professionals about new risks associated with already-approved healthcare products.

Categories: News, US, CDER, Drugs, Postmarket surveillance

Tags: Wikipedia, Drug Safety, Safety, Drug Safety Communication, Internet

CDRH, CBER Finalize Medical Device Review Communication Guidance By Alexander Gaffney, RAC - Published 03 April 2014

Categories: US, FDA, CBER, CDRH

Tags: Substantive Interactions, Acceptance Review, Interactive Review, BLA, Communication, Latest News, 510(k), PMA, guidance

FDA Expresses Interest in Increasing Impact, Reach of Safety Warnings By Alexander Gaffney, RAC - Published 03 January 2014

Categories: US, FDA

Tags: RCAC, Communication, risk

Legal Issues in Digital Pharmaceutical Communication in the EU--Part 3 By Anne-Catherine Maillols-Perroy, Yves Th. Tillet - Published 10 June 2013

In the final article in a three-part series, the authors detail issues with the regulation of application software intended for medical use in the EU.

Categories: Features, Europe

Tags: Web 2.0, Digital Communication, Social Pharma, marketing, advertising, social media, EU

Regulatory Issues in Digital Pharmaceutical Communications in the EU--Part 1 By Anne-Catherine Maillols-Perroy, Yves Th. Tillet - Published 25 April 2013

The use of eHealth systems and services-defined as healthcare practice using the Internet-offers great potential to improve health systems, and will likely become increasingly common. However, before adopting eHealth technology, healthcare stakeholders should carefully consider the risks and identify legal concerns.

Tags: Communication, pharmaceutical, marketing, media, drug, EU

New Regulatory Tools Requested to Study Messaging of Regulators, Industry By Alexander Gaffney, RF News Editor - Published 07 January 2013

Categories: FDA

Tags: Solicitation, Bid, Communication, Latest News, regulatory science, safety

Report: Clashes Between White House, FDA Frequent By Alexander Gaffney - Published 03 April 2012

Categories: FDA

Tags: Popcorn, Sunscreen, Primatene, White House, Sunstein, Report, Plan B, Sebelius, Communication, Latest News, Hamburg, Obama

FDA Releases New Safety Communication Strategy By Alexander Gaffney - Published 08 March 2012

Categories: FDA, CBER, CDER

Tags: Public, Communication, Latest News, FDAAA, safety, information

Study: Letters to Doctors Have Varied Impact on Utilization By Alexander Gaffney - Published 19 January 2012

Categories: FDA

Tags: Black Box, Public, Dear Doctor Letters, Communication, Latest News, REMS