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Womble Bond Dickinson

FDA Updates Guidance on Intentional Genomic Alterations in Animals

Womble Bond Dickinson on

Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more

Bass, Berry & Sims PLC

FDA Issues Updated Guidance on Clinical Trial Conduct during the COVID-19 Pandemic

Bass, Berry & Sims PLC on

Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more

Hogan Lovells

To certify or not to certify? FDA has answered the question

Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Releases Draft Guidance on Biosimilars - Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity

McDonnell Boehnen Hulbert & Berghoff LLP on

The Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its...more

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