Joanne Hawana

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FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence

The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...more

9/28/2022 / CLIA , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Infectious Diseases , New Guidance , Public Health , Virus Testing

With Release of New Guidance, FDA Signals It’s Serious About Enforcing Clinical Trial Data Requirements

Clinical trial sponsors and principal investigators can consider themselves on notice that the Food & Drug Administration (FDA) is poised to ramp up enforcement activity relating to responsible parties’ obligations regarding...more

8/21/2020 / CDRH , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Clinical Trials , Final Rules , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , National Institute of Health (NIH) , New Guidance , Pharmaceutical Industry

FDA Finalizes Genetically Engineered Food Labeling Guidance & Approves “AquAdvantage Salmon”

Last week will undoubtedly be marked in the annals of Food and Drug Administration history as an important milestone for the Agency. On November 19, 2015, FDA approved the first genetically engineered (GE) animal intended for...more

11/30/2015 / FDA Approval , Food and Drug Administration (FDA) , Food Labeling , GMO , New Guidance , Salmon

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more

7/1/2015 / Food and Drug Administration (FDA) , Healthcare , New Guidance , Pharmacies , Prescription Drugs , Supply Chain

More Biosimilar Q&A’s Released by FDA

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called...more

5/15/2015 / Biosimilars , Food and Drug Administration (FDA) , New Guidance , Prescription Drugs

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