Search Results for Puerto Rico

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FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria By Zachary Brennan - Published 11 October 2017

Baxter Healthcare said in letters to health care professionals dated Monday that it is working with the US Food and Drug Administration (FDA) to import sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria.

Categories: News, US, FDA, Crisis management, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Baxter, drug shortages, Puerto Rico, Hurricane Maria

MedTech Industry Sees Challenges in Restarting Operations, Helping Puerto Rico By Zachary Brennan - Published 25 September 2017

With more than three million Americans in Puerto Rico facing no electricity because of Hurricane Maria, medical device and biopharmaceutical companies are doing what they can to work with the US government to help their employees and restart operations.

Categories: News, US, Drugs, Manufacturing, Medical Devices

Tags: AdvaMed, Department of Commerce, Puerto Rico

Rare FDA Warning Letter Shows Spanish Drug Claims no Match for Agency Translators By Alexander Gaffney, RAC - Published 05 August 2014

A Warning Letter issued this week by the US Food and Drug Administration (FDA) to a marketer of pharmaceutical products is a rare example of FDA cracking down on promotional claims made in Spanish and aimed at an audience outside the continental US.

Categories: News, US, CDER, Compliance, Drugs, Labeling

Tags: Warning Letter, Spanish, Espanol, Promotional, Labeling, Misbranding, Puerto Rico