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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Shana Cyr ordered by Published Date Descending.
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FDA Final Guidance On Immunogenicity Testing Of Therapeutic Protein Products
On January 23, 2019, FDA issued final guidance on immunogenicity testing of therapeutic protein products.
United States
4 Feb 2019
2
FDA Final Guidance On Physiologically Based Pharmacokinetic Analyses
On September 4, 2018, the FDA issued final guidance on Physiologically Based Pharmacokinetic Analyses — Format and Content.
United States
17 Sep 2018
3
SaMD Series: The Interplay Between IP And FDA Submissions
Software as a Medical Device – also referred to as SaMD – is one of the fastest growing innovations in the medical device industry
United States
6 Aug 2018
4
Dead Zone: Are Your Biological Products Ready For FDA's Regulatory Transition?
On that date, FDA will replace all approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for biologics with biologic license applications (BLAs) or abbreviated...
United States
1 Jun 2017
5
Combination Products: Regulatory And Patent Issues You Should Consider Now
Products involving combinations of drugs, biological products, and medical devices are becoming increasingly prominent. Combination products can involve components that are physically...
United States
31 Mar 2017
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