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FDA Emergency Use Authorizations (EUAs): Cutting Regulatory Red Tape for COVID-19

In response to the COVID-19 outbreak in the United States, the Food and Drug Administration (FDA) has issued an increasing number of EUAs, now in the double digits, for in vitro diagnostic (IVD) products and personal...more

FDA and State Boards of Pharmacy React to Coronavirus – March 27 Update

The U.S. now has the most confirmed coronavirus cases in the world, and the FDA and state boards of pharmacy are issuing daily guidance on how to stop the spread or join in the fight through relaxed standards or expedited...more

FDA and Pharmacy Weekly Digest - March 2020 #4

As the response to COVID-19 consumes more and more healthcare, industry and regulatory resources, developments in the FDA and pharmacy space not relating to COVID-19 are limited. When other developments are available, the FDA...more

FDA and State Boards of Pharmacy React to Coronavirus – March 19 Update

The Food and Drug Administration (FDA) and the state boards of pharmacy continue to issue guidance and policy daily. Now, the Drug Enforcement Administration (DEA) has joined in to provide guidance to industry and healthcare...more

FDA and Pharmacy Weekly Digest - March 2020 #3

Coronavirus (COVID-19) - The FDA and Pharmacy Weekly Digest will continue to provide weekly coverage of the FDA and the pharmacy sector during the current public health emergency....more

FDA and State Boards of Pharmacy React to Coronavirus

The new coronavirus continues to be the leading global news headline. We have established a comprehensive online resource center to help address and answer legal questions about coronavirus disease 2019 (COVID-19). ...more

FDA and Pharmacy Weekly Digest - March 2020 #2

FDA Launched Webpage on Agricultural Biotechnology – The webpage is part of the Feed Your Mind education initiative to help consumers better understand genetically engineered foods, commonly called GMOs or genetically...more

FDA Alerts Compounders of a Major Change in Practice

With just days remaining until the “Deemed to Be a License” transition takes effect, the FDA issued an unexpected sweeping change to compounding practice. ...more

FDA and Pharmacy Weekly Digest - March 2020 #1

Food/Dietary Supplements - FDA Extended the Comment Period for the Laboratory - Accreditation Program Proposed Rule – Once the laboratory accreditation program is established, the FDA will require that the testing of food...more

FDA and Pharmacy Weekly Digest - February 2020 #4

Food/Dietary Supplements - FDA Released a Supplemental Draft Guidance for the Intentional Adulteration Rule Under the Food Safety Modernization Act – The Food & Drug Administration (FDA) announced the availability of a...more

FDA and Pharmacy Weekly Digest - February 2020 #3

Food/Dietary Supplements - FDA and CDC Announced the End of a Salmonella Outbreak in Fresh Fruit – The Food & Drug Administration (FDA) completed its investigation into an outbreak of illnesses caused by Salmonella that...more

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