USACE completes $10M FDA San Juan Campus expansion
March 26, 2025
The new FDA annex building and three other room renovations in the main building will enhance the federal agency’s work in Puerto Rico. #NewsismyBusiness
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Pace Life Sciences gets positive FDA review at San Germán plant
April 2, 2024
The operation in Puerto Rico includes a team of more than 60 bilingual chemists and microbiologists. #NewsismyBusiness
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Puerto Rico trials could lead PapEasy to revolutionize cervical cancer screening
December 1, 2023
CEO says the device will create hundreds of manufacturing and other jobs. PapEasy and Ana G. Méndez University will host a cervical cancer symposium today. #NewsismyBusiness
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Op-Ed: FDA says ‘shortage of IV fluids will improve in coming weeks, months’
January 17, 2018
Earlier this month, we updated on the Food and Drug Administration’s efforts to mitigate ongoing IV saline shortages that resulted from, or were worsened by, the devastating impact of Hurricane María in Puerto Rico. We also provided some additional updates related to our continued efforts to help the island fully recover from this disaster.
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Op-Ed: FDA chief, ‘shortage of IV fluids will improve in early ’18’
January 5, 2018
As we enter the new year and pass the 100-day mark from when Hurricane María made landfall in Puerto Rico, we want to provide an update on the current recovery efforts, the state of existing drug shortages that resulted from the impact of the storm and our continued commitment to help the island fully recover.
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Op-Ed: Mitigating medical product shortages will require ‘sustained effort’
December 1, 2017
While Puerto Rico is making progress in its effort to recover from the devastation left by the hurricanes, it remains a long process and there's a lot of work left to do. At the Food & Drug Administration, we're vigilant about helping address the challenges that remain.
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FDA Chief: Hurricane María disruptions ramifications hit patients in PR, US
November 18, 2017
It's been nine weeks since Hurricane Maria made landfall on Puerto Rico and the island continues to struggle to recover from the devastation brought by this storm, as well as Hurricane Irma.
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FDA acts to avoid shortages of medications made in PR
September 27, 2017
The head of the U.S. Food and Drug Administration, Scott Gottlieb said this week the agency is “doing all it can” to support the immediate needs of Puerto Ricans after Hurricane María’s destruction, as well as ensure supplies of critical drugs produced on the island.
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Pharma Consulting Corp. marks 13 years of growth
August 23, 2016
Local multidisciplinary company Pharma Consulting Corp. is marking its 13th anniversary by strengthening its services in Puerto Rico, as well as its footprint in the Central and Latin American regions, company President Charil Pabón said Monday.
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CBP reaches out to P.R.’s trade sector on ACE transition
January 28, 2016
The U.S. Customs and Border Protection San Juan Office of Field Operations hosted Wednesday the Automated Commercial Environment (ACE) Symposium to familiarize the local trade community about the transition to a single window for import and export reporting.
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Pharma Industry Assoc. hosting 12th annual meeting
June 18, 2014
The Pharmaceutical Industry Association of Puerto Rico and the federal Food and Drug Administration will host the FDA/PIA 12th Regulatory Meeting Thursday at the Ritz-Carlton San Juan, from 7:30 a.m. to 5 p.m, the trade group announced.
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FDA fires off warning letter to Integra LifeSciences Añasco
February 20, 2013
Medical device manufacturer Integra LifeSciences Holdings Corp. was on the receiving end of a warning letter from the U.S. Food & Drug Administration last week, in which it was cited over concerns relating to process validations, corrective and preventative actions, as well as document controls, at its Añasco plant.
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FDA approves new meds for rheumatoid arthritis, ADHD
December 19, 2012
The U.S. Food and Drug Administration recently gave the go-ahead to two new drugs, Xeljanz and Quillivant XR, to treat rheumatoid arthritis and Attention Deficit Hyperactivity Disorder, respectively, the manufacturing companies announced in separate statements.
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FDA admonishes Warner Chilcott over birth control pill production in Fajardo
March 13, 2012
The Food and Drug Administration has issued a stern warning to pharmaceutical manufacturer Warner Chilcott Company, LLC in Fajardo for not taking sufficient corrective action related to its birth control pill production.
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Study: P.R. drug plant quality issues linked to cultural differences, knowledge transfer gaps
September 7, 2011
Drugs produced in U.S.-owned and operated pharmaceutical manufacturing plants in Puerto Rico are more likely to have quality problems than those produced by the same firm in a matched plant on the mainland, a study released Tuesday by Ohio State University's Fisher College of Business.
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