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FDA

FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs

September 20, 2021

FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs

The following quote is attributed to Theresa M. Michele, M.D., director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and…

FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs FDA
Coronavirus (COVID-19) Update: September 17, 2021

September 17, 2021

Coronavirus (COVID-19) Update: September 17, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On Sept. 17, the…

Coronavirus (COVID-19) Update: September 17, 2021 FDA
FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

September 17, 2021

FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

The U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases…

FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions FDA
Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions

September 17, 2021

Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions

The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction that prohibits a Florida-based company from producing…

Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions FDA
FDA In Brief: FDA Hosts Third Summit Focused on Reducing the Availability of Opioids Online

September 17, 2021

FDA In Brief: FDA Hosts Third Summit Focused on Reducing the Availability of Opioids Online

The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D “The opioid crisis continues to be a national public health emergency with devastating…

FDA In Brief: FDA Hosts Third Summit Focused on Reducing the Availability of Opioids Online FDA
FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation

September 15, 2021

FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation

Today, the U.S. Food and Drug Administration announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office…

FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation FDA
FDA In Brief: FDA Announces Winners of Food Traceability Challenge

September 13, 2021

FDA In Brief: FDA Announces Winners of Food Traceability Challenge

The following quote is attributed to Frank Yiannas, Deputy Commissioner for Food Policy and Response “In June, we launched the New Era of Smarter Food…

FDA In Brief: FDA Announces Winners of Food Traceability Challenge FDA
Coronavirus (COVID-19) Update: September 10, 2021

September 10, 2021

Coronavirus (COVID-19) Update: September 10, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, the FDA posted…

Coronavirus (COVID-19) Update: September 10, 2021 FDA
FDA Will Follow The Science On COVID-19 Vaccines For Young Children

September 10, 2021

FDA Will Follow The Science On COVID-19 Vaccines For Young Children

As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are…

FDA Will Follow The Science On COVID-19 Vaccines For Young Children FDA
FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted

September 9, 2021

FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted

The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D., and Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products On this…

FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted FDA

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