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FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens

September 24, 2021

FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens

The U.S. Food and Drug Administration today took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of…

FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens FDA
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

September 22, 2021

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single…

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations FDA
FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

September 22, 2021

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

Today, the U.S Food and Drug Administration issued for public comment two draft guidance documents that, if finalized, will help manufacturers of animal cells, tissues,…

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals FDA
FDA In Brief: FDA Publishes Material Safety Data to Promote Safer, More Effective Medical Devices

September 22, 2021

FDA In Brief: FDA Publishes Material Safety Data to Promote Safer, More Effective Medical Devices

The following quote is attributed to Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories in the FDA’s Center for Devices and…

FDA In Brief: FDA Publishes Material Safety Data to Promote Safer, More Effective Medical Devices FDA
FDA Authorizes Software that Can Help Identify Prostate Cancer

September 21, 2021

FDA Authorizes Software that Can Help Identify Prostate Cancer

Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas…

FDA Authorizes Software that Can Help Identify Prostate Cancer 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 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
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 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

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